Podcasts about warning letter

FDA Follies! Dr. Ott's mineral company just received a "Warning Letter" from the FDA.   While it is perfectly ok to put highly toxic experimental mRNA "vaccine" particles into veggies like lettuce and tomatoes, as well as "wild" salmon and hen-laying chickens https://www.youtube.com/watch?v=3gyJYdFmYRI&t=4s, pure elemental minerals and pure water is being targetted as "illegal drugs".  Share this horror story widely!

Vous avez un backlog de déviations ? Vous pensez que ce n'est pas trop grave ? La FDA a un tout autre avis sur la question… L'analyse de la « warning letter » suivante (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sanofi-690604-01152025) nous révèle dans les grandes lignes ce que la FDA pense du processus de gestion des déviations. Pour rappel, une « warning letter » fait suite à une réponse jugée insatisfaisante à un formulaire 483 (écart d'audit FDA), et ces lettres sont rendues publiques sur le site de la FDA. Dans celle-ci, on découvre entre autres que le site avait un backlog de 83 déviations en retard. Quatre exemples sont cités, avec un retard allant de 187 jours à 45 jours. C'est moche, mais j'ai déjà vu bien pire… Dans leur réponse, le site met en évidence quatre causes principales : ➡️Une rotation excessive du personnel expérimenté ➡️Un manque de connaissances process chez les nouveaux enquêteurs ➡️Une focalisation sur les lots en attente de libération ➡️Une communication incohérente des indicateurs de performance liés aux déviations On ne fait pas plus classique : le processus de gestion des déviations n'est pas porté à sa juste valeur, pas de méthode d'investigation pour former les nouveaux enquêteurs et probablement aucun pilotage. La FDA a d'ailleurs très bien perçu la situation. La promesse de ressources supplémentaires (nouveaux enquêteurs, experts externes, etc.) a été jugée insuffisante ☠️. Selon la FDA, il manque des détails sur l'implémentation concrète : l'impact sur les autres opérations, la formation des nouveaux intervenants et le suivi de leur performance… Bref, ils veulent de la méthode et du pilotage ! Si vous êtes dans ce cas-là et que vous ne savez pas du tout quoi faire, n'hésitez pas à nous appeler. Retrouvez l'épisode complet ici : Bonne écoute !

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week: The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand. The bad — Merck KGaA's CDMO business reports a decline The ugly — The FDA issues a warning letter to Granules India over manufacturing violations

A Wellington law firm is defiant in the face of complaints to the police and the Law Society over a letter sent to doctors who practise gender affirming care. Franks Ogilvie director Stephen Franks says the letter was sent out earlier this month to more than 20 practices which were on a list supplied by the firm's client Inflection Point NZ. Bill Hickman has more.

A warning letter's been sent out by a school in Margate as a number of pupils have fallen ill.There's been an outbreak of respiratory and gastrointestinal sickness at Hartsdown Academy.Also on today's podcast, plans for a major transformation of Folkestone harbour have been rejected.The shock decision came at a meeting last night with councillors on the planning committee raising concerns about the proposals for new homes and commercial units on the seafront.The ideas had been submitted by Sir Roger De Haan's Folkestone Harbour & Seafront Development Company.People living on an estate near Maidstone say they've had to pay out £50,000 of their own money to try and sort a sewage issue.Blockages, leaks and overspills have been affecting Castor Park in Allington over the past year.Southern Water bosses have been grilled by MPs after deciding to bills by more than any other firm in the UK.Customers in Kent will be among those paying 53% more over the next five years.A Gravesend mum who's been diagnosed with stage four brain cancer is calling for better access to scans.Kelly Heather had initially been told she had a non-spreadable melanoma in 2017.And, Firefighters in Kent have unveiled their latest piece of kit, a robot.It's one of the first of its kind in the UK and will help keep crews safe as well as reduce the amount of time spent at incidents.

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:   The good — FDA approves Sun Pharma hair loss drug  The bad — FDA issues harsh warning letter to Indian CDMO Brassica  The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug 

Email Lennie at lennielawson2020@gmail.com

Veeva Site Vault: https://sites.veeva.com/Versatrial: http://www.versatrial.ioCRIO: http://www.clinicalresearch.ioInato: https://go.inato.com/3VnSro61nHealth: https://1nhealth.com/Join me at my conference! http://www.saveoursites.comText Me: (949) 415-6256My podcast is Random Musings From The Clinical Trials GuruListen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7aGET THE BOOK! https://www.amazon.com/Comprehensive-Guide-Clinical-Research-Practical/dp/1090349521/ref=sr_1_1?keywords=Dan+Sfera&qid=1691974540&s=audible&sr=1-1-catcorrText "guru" to 855-942-5288 to join VIP list!My blog: http://www.TheClinicalTrialsGuru.comMy CRO and Site Network: http://www.DSCScro.comMy CRA Academy: http://www.TheCRAacademy.comMy CRC Academy: http://www.TheCRCacademy.comLatinos In Clinical Research: http://www.LatinosinClinicalResearch.comThe University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/My TikTok: DanSferaLifeBoost Coffee: https://lifeboostcoffee.com/products/biotics-brew?_pos=2&_sid=576df78bc&_ss=r&nb_platform=shareasale

Veeva Site Vault: https://sites.veeva.com/Versatrial: http://www.versatrial.ioCRIO: http://www.clinicalresearch.ioInato: https://go.inato.com/3VnSro61nHealth: https://1nhealth.com/Join me at my conference! http://www.saveoursites.comText Me: (949) 415-6256My podcast is Random Musings From The Clinical Trials GuruListen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7aGET THE BOOK! https://www.amazon.com/Comprehensive-Guide-Clinical-Research-Practical/dp/1090349521/ref=sr_1_1?keywords=Dan+Sfera&qid=1691974540&s=audible&sr=1-1-catcorrText "guru" to 855-942-5288 to join VIP list!My blog: http://www.TheClinicalTrialsGuru.comMy CRO and Site Network: http://www.DSCScro.comMy CRA Academy: http://www.TheCRAacademy.comMy CRC Academy: http://www.TheCRCacademy.comLatinos In Clinical Research: http://www.LatinosinClinicalResearch.comThe University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/My TikTok: DanSferaLifeBoost Coffee: https://lifeboostcoffee.com/products/biotics-brew?_pos=2&_sid=576df78bc&_ss=r&nb_platform=shareasale

Sponsored by Fidei Email: https://www.fidei.email Sources: https://www.returntotradition.org Contact Me: Email: return2catholictradition@gmail.com Support My Work: Patreon https://www.patreon.com/AnthonyStine SubscribeStar https://www.subscribestar.net/return-to-tradition Buy Me A Coffee https://www.buymeacoffee.com/AnthonyStine Physical Mail: Anthony Stine PO Box 3048 Shawnee, OK 74802 Follow me on the following social media: https://www.facebook.com/ReturnToCatholicTradition/ https://twitter.com/pontificatormax https://www.minds.com/PiusXIII https://gloria.tv/Return%20To%20Tradition Back Up https://www.bitchute.com/channel/9wK5iFcen7Wt/ anchor.fm/anthony-stine +JMJ+ --- Support this podcast: https://podcasters.spotify.com/pod/show/anthony-stine/support

Pink Sheet reporters and editor discuss a projected list of drugs that could be eligible for the first round of Medicare price negotiations (:40), the future of mifepristone access after the latest court decision (9:24), and AstraZeneca receiving the first US FDA drug promotion warning letter in more than a year (21:55). More On These Topics From The Pink Sheet Medicare Price Negotiation List Remains A Puzzle, Even For Those That Are (Probably) On It: https://pink.pharmaintelligence.informa.com/PS148718/Medicare-Price-Negotiation-List-Remains-A-Puzzle-Even-For-Those-That-Are-Probably-On-It Mifepristone REMS Modifications Likely Violated Administrative Procedure Act, Appeals Court Says: https://pink.pharmaintelligence.informa.com/PS148721/Mifepristone-REMS-Modifications-Likely-Violated-Administrative-Procedure-Act-Appeals-Court-Says Breaking Down The Arguments In The Mifepristone Case: https://pink.pharmaintelligence.informa.com/PS148678/Breaking-Down-The-Arguments-In-The-Mifepristone-Case The Mifepristone Story So Far: Tracing The Origins Of The Legal Fight Over The Abortion Pill: https://pink.pharmaintelligence.informa.com/PS148679/The-Mifepristone-Story-So-Far-Tracing-The-Origins-Of-The-Legal-Fight-Over-The-Abortion-Pill AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don't Balance Graphics: https://pink.pharmaintelligence.informa.com/PS148710/AstraZeneca-Gets-Rare-Warning-Letter-Over-Breztri-Sales-Aid-Footnotes-Dont-Balance-Graphics

Vicki Dillard reports on the White House sending an African reporter a warning letter to behave in the press briefing room. --- Send in a voice message: https://podcasters.spotify.com/pod/show/africandiasporanews/message Support this podcast: https://podcasters.spotify.com/pod/show/africandiasporanews/support

Hey BillOReilly.com Premium and Concierge Members, welcome to the No Spin News for Wednesday, July 19, 2023. Stand Up for Your Country. Tonight's rundown:  Talking Points Memo: Bill delves into Jack Smith's letter to Donald Trump. Sen. Ted Cruz joins the No Spin News, where he talks about the 2024 campaign, the Biden Family investigation, and the new push for Kate's Law. The latest on the IRS whistleblowers testifying before the House Oversight Committee. Why is Merrick Garland being sued over Hunter Biden? This Day in History: Don't Ask, Don't Tell Final Thought: Passivity In Case You Missed It: Read Bill's latest column, "Twilight in the Politics Zone." It's the 'Summer Reading Special!' 'Killing the Killers,' Killing the Legends,' and 'Killing Crazy Horse' all for $32.95. We'll also give you a FREE 'Team Normal' hat. Bill takes your questions live Monday, July 24th on BillOReilly.com. The Biden Family Investigation is a Premium & Concierge Member exclusive town hall. Sign up today! Learn more about your ad choices. Visit megaphone.fm/adchoices

Last week, seven Attorney's General from different states, including Idaho's Raúl Labrador, addressed a letter to Target warning that products sold as part of its Pride Month Campaign could violate state protection laws.

The FDA clearance of Getinge's non-invasive mechanical ventilator showcases the ongoing efforts to develop advanced respiratory devices that can provide critical support to patients in need. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the ventilator does and when patients can expect the ventilators to hit the market. PainTEQ's successful fundraising round will expand the commercialization of its LinQ implantable sacroiliac (SI) joint stabilization system. Whooley explains the technology behind the device and the company's success in previous procedures using the device. Chief financial officers play a crucial role in driving financial strategies, ensuring regulatory compliance, and supporting business growth and sustainability, and Fresenius Medical Care appointed a new one to its executive team. Hear how the appointee's career history supports their appointment and how optimistic executives are in today's episode.  The U.S. Federal Trade Commission wants to have a say in Applied Medical Resources' antitrust lawsuit against Medtronic. Whooley and Kirsh discuss the ongoing lawsuit, why Medtronic wants to dismiss the lawsuit and what the FTC has to say about it. The decline in Outset Medical's stock following the receipt of an FDA warning letter demonstrates the impact that regulatory compliance and product quality have on investor confidence. The Fast Five hosts discuss the details in the warning letter and if it will affect Outset Medical's production of devices. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

The FDA clearance of Teleflex's Wattson temporary pacing guidewire represents an important milestone in cardiac care for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain how the technology works and what executives hope to achieve with the device.  Inari Medical's launch of its RevCore and Triever16 Curve catheters marks a significant development in the field of endovascular care. These catheters offer advanced capabilities for the treatment of venous and arterial diseases, providing physicians with enhanced tools for precise and minimally invasive interventions. Whooley details what the catheters do and the reception the devices have had from doctors.  Know Labs' non-invasive glucose monitoring prototype showcases the company's dedication to developing advanced technologies that improve the lives of individuals with diabetes. By offering a non-invasive glucose monitoring option, this device has the potential to enhance patient compliance, simplify self-care routines, and empower individuals with real-time glucose data. The Fast Five hosts discuss how the technology could be incorporated into everyday wearables.  The appointment of former Insulet CEO Shacey Petrovic to the board of directors at Imperative Care highlights the valuable expertise and leadership she brings to the medical device industry. Hear more about the vast experience she brings to the company and how optimistic executives are. The FDA warning letter addressed to iRhythm, outlining alleged violations and patient deaths, sheds light on the critical importance of adherence to regulatory standards and patient safety in the medical device industry. Whooley details all of the violations in the letter and iRhythm's response to the allegations. Check out the show notes at MassDevice.com/podcast for insights into today's episode.

The global release of Exactech's next-generation GPS Shoulder system marks an important milestone in shoulder arthroplasty. The launch, taking place in EMEA and APAC countries, follows the first surgery in the United Arab Emirates earlier this month. Fast Five Hosts Danielle Kirsh and Chris Newmarker share details about the orthopedic device and what doctors think of the system. With a new CE mark, Establishment Labs has completed a full transition of all currently marketed Motiva implants and tools, as well as the company's quality management systems, to be in compliance with the new European Medical Device Regulation (MDR). Newmarker explains the devices included in the new indication and what surgeons and executives think about it. The FDA's breakthrough designation for CardioRenal's Tenor at-home blood potassium measuring device signifies a significant advancement in monitoring and managing blood potassium levels in patients. This innovative device enables individuals to conveniently and accurately measure their potassium levels from the comfort of their own homes. Kirsh and Newmarker explain the benefits of at-home monitoring and how Tenor works. The clash between Masimo management and activist investor Politan has brought attention to the strategic direction and governance of the company. With differing perspectives on key decisions and company performance, this dispute highlights the challenges faced by organizations in managing shareholder expectations. Newmarker details the disagreement between the two parties and who on the board of directors is up for a vote. iRhythm's receipt of an FDA warning letter regarding its Zio AT quality systems highlights the importance of robust quality control measures in the medical device industry. iRhythm's response to the FDA warning letter and its actions to address the identified issues will be closely watched by regulators. Hear more about the warning letter from the Fast Five hosts.

The global release of Exactech's next-generation GPS Shoulder system marks an important milestone in shoulder arthroplasty. The launch, taking place in EMEA and APAC countries, follows the first surgery in the United Arab Emirates earlier this month. Fast Five Hosts Danielle Kirsh and Chris Newmarker share details about the orthopedic device and what doctors think of the system. With a new CE mark, Establishment Labs has completed a full transition of all currently marketed Motiva implants and tools, as well as the company's quality management systems, to be in compliance with the new European Medical Device Regulation (MDR). Newmarker explains the devices included in the new indication and what surgeons and executives think about it. The FDA's breakthrough designation for CardioRenal's Tenor at-home blood potassium measuring device signifies a significant advancement in monitoring and managing blood potassium levels in patients. This innovative device enables individuals to conveniently and accurately measure their potassium levels from the comfort of their own homes. Kirsh and Newmarker explain the benefits of at-home monitoring and how Tenor works. The clash between Masimo management and activist investor Politan has brought attention to the strategic direction and governance of the company. With differing perspectives on key decisions and company performance, this dispute highlights the challenges faced by organizations in managing shareholder expectations. Newmarker details the disagreement between the two parties and who on the board of directors is up for a vote. iRhythm's receipt of an FDA warning letter regarding its Zio AT quality systems highlights the importance of robust quality control measures in the medical device industry. iRhythm's response to the FDA warning letter and its actions to address the identified issues will be closely watched by regulators. Hear more about the warning letter from the Fast Five hosts. Check out the show notes at MassDevice.com/podcast.

In this episode of MedtronicTalks, Que Dallara, EVP and President of the Diabetes Business at Medtronic, discusses the company's recent advancements in diabetes management. Dallara, transitioning from the software and technology industry to the medical device industry, draws parallels between control systems in different fields and their application to diabetes management, particularly in the development of closed-loop algorithms for insulin dosing. She also highlights the FDA-approved MiniMed 780G system, which simplifies diabetes management with automatic adjustments for insulin dosing and carbohydrate counting. Finally, Dallara addresses Medtronic's ongoing engagement with the FDA and news of the launch of the MiniMed 780G system in the U.S., sharing more about its meal detection technology and benefits. Thank you to GlobalMed-MDI for sponsoring this episode. To learn more about how GlobalMed-MDI works with medical device companies, visit www.moldeddevices.com. Thank you for listening to the Medtronic Podcast. Subscribe to this podcast on every major podcast platform.

Patients with diabetes rely on certain devices for their daily management, and it is vital that they have confidence in the safety and effectiveness of their products. On today's episode, Hosts Danielle Kirsh and Sean Whooley detail how medtech giant Medtronic resolved its earlier FDA warning letter related to its diabetes business. GE Healthcare recently launched its next-generation intraoperative ultrasound technology, a significant advancement in medical imaging. Whooley discusses how the technology could streamline physician workflow in the operating room. Non-invasive biometric monitoring is on the horizon. Fast Five hosts Kirsh and Whooley discuss CardieX's recent FDA clearance and how it could allow healthcare providers to monitor blood pressure and central blood pressure using arterial waveform analysis. Despite an earnings season full of economic headwinds, Boston Scientific nearly tripled its profits in Q1. This is a positive sign for the medical device industry as it indicates a healthy market and ongoing innovation. Whooley gives an in-depth look at the company's financial performance and how optimistic CEO Mike Mahoney is. Finally, Medtronic's Endurant stent graft system showed durable outcomes in a 10-year post-market registry. Shown to be safe and effective, Whooley details what the device is indicated for and how it could lead to improved patient outcomes and a better quality of life. Check out the show notes at massdevice.com/podcast.

Various engineers, researchers, and tech innovators signed an open letter urging for a pause on A.I. work, a bipartisan group of senators have teamed up to support a bill to “ban” Tik Tok while others say it's a trojan horse, and a college professor is on leave after calling for the murder of racists and homophobes. Get the facts first with Morning Wire. Black Rifle Coffee: Get 10% off your first order or Coffee Club subscription with code WIRE: https://www.blackriflecoffee.com/Cynch: Download the Cynch app and get your first tank exchange for just $10 with promo code WIRE. Visit http://cynch.com/offer for details.

Jonathan Miller interviews Vince Sanders, CEO of American Shaman, about FDA's actions and inaction and the impact on the future of the hemp and CBD industries. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questions covered in the episode: How does American Shaman operate a franchise CBD store business operation and what's been the progress of this model? How has FDA's inaction on CBD regulations impacted the retail marketplace? What has been American Shaman's response to the growth of minor cannabinoids such as delta-8 THC? What was the content of FDA's Warning Letter to American Shaman, and how has the company responded? How concerned should we be about the future of the hemp and CBD industries?

Ben Fordham has shared the letter Fr Frank Brennan wrote to the PM on the 9th of November.See omnystudio.com/listener for privacy information.

On this episode, Asa Waldstein, Principal @ Supplement Advisory Group, joined the show to discuss FDA Enforcement Trends for 2023, Social Media Compliance, and his weekly newsletter, Warning Letter Wednesday.Asa is a Certified Clinical Herbalist and a 20-year dietary supplement executive. Asa's consulting company, Supplement Advisory Group, is a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. He chairs the American Herbal Products Association's (AHPA) Cannabis Committee. 

Hello everyone! This week me and Jorge talk about personal responsibility concerning the workplace. How people have changed their thinking from responsibility to deflection.

Last week, the US Food and Drug Administration (FDA) sent out warning letters to five companies illegally selling CBD-infused food and beverage products. In this episode of the Xtalks Food Podcast, Sydney talks about the contents of the warning letters and the FDA's rules regarding CBD. Currently, the use of CBD in food and beverage products is an unapproved food additive in the US. the agency also cited safety concerns regarding accidental or overconsumption of CBD, as well as drug interactions. Of particular concern to the FDA are dosage formats that appeal to children such as gummies, hard candies and cookies.  Perhaps warning letters were sent out to these five companies since four of them sell CBD-infused candies or gummies. The team wonders why the FDA doesn't take stricter regulatory action when it comes to CBD and whether there are any benefits of consuming CBD-infused products. Also, in this episode, Sydney talks about the rise of alcohol free beverages. As the desire for no- and low-alcohol beverages increases and producers are responding to consumer demands, the industry is taking note and investing in products aimed at consumers keen to celebrate on their own terms. Since almost half of drinkers said they are trying to reduce their alcohol consumption right now, and 52 percent of them are replacing alcohol with alcohol free beverages, the non-alcoholic beer, wine and cocktails category is surging in popularity. Some of the biggest players in the beverage industry are making moves into the non-alcoholic market, which is estimated to reach $538 million by 2026. The team has mixed feelings when it comes to alcohol free beverages, but all agree that they promote inclusivity and reduce the stigma of abstaining from alcohol. Read the full articles here:Companies Illegally Selling CBD-Infused Food Receive FDA Warning LettersAlcohol Free Beverages on the Rise Ahead of Holiday SeasonFor more food and beverage industry content, visit the Xtalks Vitals homepage.Follow Us on Social Media Twitter: @XtalksFood Instagram: @Xtalks Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

See omnystudio.com/listener for privacy information.

    Thabo Mdluli speaks to the Chairperson of South African Medical Association, Dr Mvuyisi Mzukwa, DA Shadow Gauteng Shadow MEC for Health, Jack Bloom and Dr Tim de Maayer's close source about Gauteng Department of health claiming that the matter relating to Dr Tim De Maayer from Rahima Moosa Mother and Child Hospital has been resolved and closed. See omnystudio.com/listener for privacy information.

Guest: Jack Bloom | Leader Of Da at Gauteng Legislature See omnystudio.com/listener for privacy information.

The Anti Y Combinator Memo In Response To Y Combinator's Warning Letter To FoundersWatch, listen or read today. Watch, listen or read today.

We just put our electric cars to the ultimate test: The MDW Road Trip (so we're taking you on our Electric Odyssey). Burger King's making burgers for pregnant women — and worshiping the Whopper. And Y Combinator just wrote a letter to all startup CEOs: Warning. $QSR $TSLA $VWAGY Follow us on Instagram, Twitter, and Tiktok: @tboypod And now watch us on Youtube Want a Shoutout on the pod? Fill out this form Got the Best Fact Yet? We got a form for that too “The Whopper is my mantra” — Burger King's worship brand. Baby Unicorns' warning letter. Our electric car odyssey. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Y Combinator's Warning Letter To Founders, Their Role In Startup Correction & Advice For Startups. Watch, listen or read today.

Today, let's talk about sending warning letters for possible patent infringement If you believe that someone is infringing your patent right in China, you may be angry and can't help to send him a warning letter(C&D letter) demanding him to stop the infringement. Sending a warning letter is indeed an option to stop infringement. However, you should be prepared before sending the warning letter or you might get unfavourable results due to haste.

Warning Letters are more than a slap on the wrist.  They are the first step in what can be a costly remediation and legal battle.  How do we prevent them? What is within the power of the FDA and government when they spot quality issues? To help us with these questions and more, we are joined by Amanda Johnston of Gardner Law. Amanda has over a decade of experience in FDA Regulatory Law and experience with all sizes of companies.To learn more about Gardener Law, check out their website: https://gardner.law/ 

Relationships oftentimes seem fine, even loving, when viewing them from the outside. It's difficult to know what may be going on behind closed doors. For one woman, her relationship began this way, with mostly everyone thinking she'd found a man whose future value would allow them to lead a very charmed life. Not long after they began dating, cracks in the relationship began to surface. Soon, people close to the couple observed disturbing behavior that made them very uncomfortable. When the woman went missing, some people quickly pointed the finger at her husband. Family members and investigators would be in for a very long journey to find out what happened, and they would be utterly flabbergasted more than once by discoveries made during the investigation into her disappearance. Join me as I walk you through the case involving Gail Katz Bierenbaum. Check us out: Visit Murderish.com for more info about the show and Creator/Host, Jami. The website also has links to buy MURDERISH merchandise and become a Patreon supporter. Patreon subscribers can get access to exclusive Patreon-only episodes. To sign up for Patreon perks, click “Go Behind the Scenes” on the website OR click here for a direct link to our Patreon page https://www.patreon.com/Murderish. Let's get social: @MurderishPodcast (Instagram), @MurderishPod (Twitter), search “Murderish podcast” (Facebook). CrimeCon: Visit CrimeCon.com to buy your badge to attend the event. Use code MURDERISH for 10% a Standard Badge. Hope to see you there! Sponsors: - Warby Parker: Visit warbyparker.com/murderish to try 5 pairs of glasses at home for free. - Seed: Visit seed.com/murderish & use code MURDERISH for 20% off your first month of Seed's Daily Synbiotic. - Calm: Visit calm.com/murderish for 40% off unlimited access to Calm's entire library. - Thrive Causmetics: Visit thrivecausmetics.com/murderish for 15% off your first order. - HelloFresh: Visit HelloFresh.com/murderish14 & use code murderish14 for up to 14 free meals PLUS three free gifts. Want to advertise on this show? We've partnered with Cloud10 | iHeartRadio to handle our advertising requests. If you're interested in advertising on MURDERISH, send an email to Sahiba Krieger mailto:sahiba@cloud10.fm with a copy to mailto:jami@murderish.com. Sound design: Justin Hellstrom. Music: Some of the music in this podcast was composed by Nico Vettese of We Talk of Dreams Research & Writing: Lincoln Edgemon. Jami's other podcast: Follow Judgey & Juryish wherever you listen to podcasts & on Instagram @JudgeyJuryish. Remember, listening to this podcast doesn't make you a murderer - it just means you're murder...ish. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Seems like the warning letter ought to arrive BEFORE the car is crushed. http://www.lehtoslaw.com

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, go over a case study where we tried to teach a client that received a warning letter life lessons for Quality Complaint investigations.Listen in as we break down how we helped this client and taught them an important life lesson for the industry while addressing their Quality Complaint warning letter.

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Executive VP of Pharmaceuticals, Steven Lynn go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations.Listen in as we break down the client's Warning Letter Remediation challenges, RCA's approach to remediation, the ongoing work still taking place, and some advice on FDA Investigation Readiness. Stay tuned for Part 2 of this case study once we have completed the entire project.

In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really operates, their main purpose during an audit, and sheds light on details you have probably never known about the FDA. Who Is Luis Charles Chavarría? Luis has served in FDA for about three decades in several capacities that have earned him an unprecedented understanding of FDA affairs. He is currently working as President/Lead Consultant at Supaso International. He has also worked with the US Department of Justice and contributed to policymaking at the national as well as on the international level. Reading the Article and Listening to the Podcast, You Will Learn About: ● What Does an FDA Agent Do? ● Difference Between an FDA Investigator and a Regular Quality Auditor ● Evidence Development by an FDA Investigator ● Procedures for Foreign-Based Manufacturing Units ------------------------------------------------------------------------------------------------------ Watch or read the full podcast and read the article at www.podcast.qualistery.com/guide-to-preparing-yourself-for-an-fda-audit/ ------------------------------------------------------------------------------------------------------ This episode is Sponsored by Dot Compliance, the industry's first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. #Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing

Angus Lee sends letter to Clark County Sheriff Chuck Atkins and Vancouver Police Chief James McElvain cautioning them against making ‘an invalid arrest.' https://loom.ly/uiQUvD0 #VancouverAttorney #AngusLee #ClarkCountySheriffsOffice #CCSO #ChuckAtkins #VancouverPoliceDepartment #VPD #JamesMcElvain #VancouverSchoolDistrict #VancouverPublicSchools #MaskMandate #Protests #InjunctionGranted #ClarkCountySuperiorCourt #JudgeSuzanClark #VancouverWa #ClarkCountyWa #ClarkCountyNews #ClarkCountyToday

Coaching & Business inquiries: thesupplementengineer@gmail.com Save 15% on Apollon Nutrition products: https://www.apollonnutrition.com/discount/Finalscoop The Final Scoop is a no-holds barred, snowflake-free panel discussion podcast born out of a desire to cut through all the fluff, frills, and BS that litters the sports nutrition and fitness industry.   Our panel includes an international assembly of industry insiders united by a common goal -- to deliver honest, straightforward information on all matters concerning training, nutrition, and supplementation sans industry-sponsored endorsements or paid advertisements. Panel members include: Shane Smith, Stack3d Robert Samborsky, Apollon Nutrition Lukasz Rytkowski, Prometeus Intelligent Sports Technology Robert Schinetsky, The Supplement Engineer Show Notes Topics covered in this installment: Arnold "Screw Your Freedom" RedCon1 Response Thoughts on Glaxon Hybrid V2 (nootropic endurance fuel) 1st Phorm warning letters structure funtion claims in the supplement industry Ambrosia Kinetic and MORE Where to Find The Final Scoop Cast Stack3D Website: https://www.stack3d.com Apollon Nutrition IG: https://www.instagram.com/apollonnutrition/ Robert Samborsky IG: https://www.instagram.com/robik2075/ Apollon Nutrition Website: https://www.apollonnutrition.com Supplement Engineer Blog: https://supplementengineer.com/blogs/supplements Supplement Engineer IG: https://instagram.com/thesupplementengineer Before You Go... If you enjoy this podcast and want to see more content like it, please consider leaving a review! https://itunes.apple.com/us/podcast/supplement-engineer-podcast/id1447389041?mt=2&ls=1

Sign up for our brand new 14-day Credit Hero Challenge.You started disputing an item from your client's credit report, sent a Round 1 Letter from your Credit Repair Cloud to the credit bureaus, waited for 30 days, but nothing happened. The bureaus either began giving you the runaround or ignored you completely.Don't worry - this happens all the time!Credit bureaus are known for their annoying stall tactics to discourage consumers from repairing their credit.But, a successful Credit Hero doesn't take no for an answer! You need to be patient and persistent if you want to beat the bureaus.Today I'm here to show you how to fight the bureaus and win!So, tune in for this episode, learn a trick or two, and never fall for their tactics again!Key Takeaways for This Week:Do the credit bureaus give you the runaround? (00:00)The way the system works (02:58)This is when the clock begins (04:36)Your next move depends on the response you got (06:12)When do you send a warning letter? (09:35)Additional Resources:- Get a free trial to Credit Repair Cloud- Get my free credit repair trainingMake sure to subscribe so you stay up to date with our latest episodes!

'13 year olds are winning medals at the Olympics... When I was 13, the only thing on my mind was worrying about slow dancing with girls... How do you ask them? Where do I put my hands? What do I do after the song? Do we make eye contact or no?' 'The Queen doesn't care about your parking ticket. The Queen is busy with her actual job... looking cranky on money.'

Market bulls made a smart comeback on Dalal Street on Monday as brisk buying in Reliance Industries, Bajaj twins, L&T, and Infosys helped benchmarks recoup losses. Indices started gap-down amid profit booking with the frontline S&P BSE Sensex and the Nifty50 dropping to lows of 51,936 and 15,606, respectively. However, positive cues from global peers, coupled with healthy buying in IT, PSU Bank, select pharma and FMCG counters, and RIL, helped the indices end the session in the positive territory. The frontline Sensex index fluctuated 655 points intra-day before settling 77 points, or 0.15 per cent, higher from previous close at 52,551 levels. The Nifty50 index, meanwhile, settled at 15,812 levels, up 13 points or 0.08 per cent. India VIX index rose 4 per cent on the NSE today, suggesting high volatility in the markets. In the broader markets, the BSE MidCap index ended the day in the red, down 0.7 per cent, amid steep losses in Adani Group stocks and BHEL while the BSE SmallCap index closed 0.2 per cent lower. Among individual stocks, shares of Adani Group companies rebounded from their respective intra-day lows on Monday after the company clarified that the demat accounts of three foreign funds - Albula Investment Fund, Cresta Fund and APMS Investment Fund - holding shares in group companies 'are not frozen'. The stocks of all six listed Adani Group companies -- Adani Enterprises, Adani Ports, Adani Power, Adani Transmission, Adani Green Energy and Adani Total Gas -- came under pressure in morning deals as they fell up to 25 per cent in intra-day trade on report that National Securities Depository Ltd (NSDL) has frozen accounts of the aforementioned FPIs that own stake in four of these group companies. However, the Group said in a statement that given the seriousness of the issue and its consequential adverse impact on minority investors, they requested Registrar and Transfer Agent, with respect to the status of the Demat Account of the aforesaid funds, and have received their written confirmation, clarifying that the Demat Account in which the aforesaid funds hold the shares of the Company are not frozen. Besides, shares of Bharat Heavy Electricals Limited (BHEL) slipped 18 per cent to Rs 62.55 on the BSE in intra-day trade on Monday after the company reported a lower-than-expected set of numbers for the quarter ended March 2021 (Q4FY21). The shares, however, settled 11 per cent lower on the BSE. Shares of Lupin also dipped 5 per cent to Rs 1,173 on the BSE in intra-day trade after the pharmaceutical company said it has received a Warning Letter for its manufacturing plant in New Jersey. However, Lupin said the company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of the facility. Lastly, shares of Godawari Power & Ispat hit a new high of Rs 1,508 after rallying 20 per cent on the BSE in intra-day trade, after the company's shareholders approved the proposal for divestment of its shareholding in Godawari Green Energy (GGEL). The stock was trading higher for the seventh straight day and has zoomed 53 per cent in the past three trading days. Sectorally, the Nifty PSU Bank index ended the day as the top gainer on the NSE, up 1 per cent, while the Nifty Realty index closed as the worst performer, down 1.4 per cent. In the primary market, the three-day IPO of Shyam Metalics sailed through on the very first day with a little over 100 per cent subscription till about 4 PM. However, the IPO on Sona Comstar failed to garner warm reception and has been subscribed just 8 per cent so far on Day 1. On the economic front, India's wholesale inflation hit a record high of 12.94 per cent in May from 10.49 per cent in April due to low base and a continued rise in fuel and commodity prices, data released by the government showed. Global markets European shares hit a record high on Monday as investors bet on global cent

Today's guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which helps companies bring life-saving products to market and scale successfully. Lisa has more than 30 years of training in the areas of manufacturing and quality assurance for the pharmaceutical, biotechnology, and medical device industries. Also, she has extensive "good practice" (GxP) knowledge of quality guidelines and regulations. She works with several startups and established companies to implement or improve quality systems and procedures.Lisa understands the challenges that industries deal with today. She describes a day-in-the-life of a quality consultant, innovations, and advice to life science entrepreneurs everywhere. Lisa has seen it all and offers some useful takeaways from her insights. Show Notes: Lisa Helmonds on LinkedInMWA ConsultingBioMarinGenentechU.S. Food and Drug Administration (FDA)FDA - Form 483 Warning Letter or Inspection ObservationFDA - Guidance DocumentsApplication to be on the show: From Lab to LaunchQualioMusic by keldez

Macron fights UK over fishing rights. French military sends second WARNING letter to Macron The Duran: Episode 967 'Civil war is brewing in France and you know it': French military launches another salvo at Macron with new open letter https://www.rt.com/news/523363-france-military-civil-war/

Get our Dispute Letter Templates for FREE: https://www.creditrepaircloud.com/dispute-letter-templates After mentoring and coaching thousands of Credit Heroes in our community, one of the most common questions remains: “What letter do I use?”Now, when you work to repair credit - it all boils down to legally harnessing the power of the Fair Credit Reporting Act and not taking no for an answer. Most credit repair companies only use a handful of letters for about 95% of their clients, so those are the letters I’m gonna focus on today. In this episode, I’m gonna go through the dispute letters EVERY credit repair business owner needs to get proven results for their clients.Key Takeaways for This Week:What to do if you need more advanced credit repair letters? (1:06)Round One Letter (2:19)Reinvestigation Letter (3:31)Method of Verification Letter (4:13)Warning Letter (5:45)Validation Demand Letter (6:52)How to modify each credit repair letter template (7:52)Get free templates for these 5 types of credit repair letters (9:01)Additional Resources:Get our Dispute Letter Templates for FREE: https://www.creditrepaircloud.com/dispute-letter-templatesGet a free trial to Credit Repair CloudSign up for the Credit Hero ChallengeGet my free credit repair trainingMake sure to subscribe so you stay up to date with our latest episodes!

Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.

ACD Spiritualism (0:43:45)↑Chase and SundayDuck pick B’s brain on Spiritualism and the Victorians’ obsession with death. ACD and Spiritualism ACD Seance Recording ACD/Houdini Breakup Image + Transcription of Houdini’s Warning Letter for ACD Cottingley Fairies The Fox Sisters Lore Episode on Spiritualism Adorable animation/song by Louie Zong used for our bumpers     This segment was first released on January 6, 2021 in Episode 112: (Un) Dead of Winter Music Credit Unless otherwise indicated, music is available for purchase through online retailers such as amazon.com and iTunes. ACD Spiritualism RT – Louie Zong, Ghost Choir: Ghost Choir Production CreditsSegment Producer: B; Editor: Chase Banner Art: Fox EstacadoDistribution funded by fans! Contact Email: bored@three-patch.comWebsite: https://www.three-patch.comFacebook: https://www.facebook.com/threepatchpodcastSkype: threepatch.podcastTwitter: https://twitter.com/threepatchTumblr: http://threepatchpodcast.tumblr.com/ How to CiteAPABy Three Patch Productions. (2021, January 6). ACD Spiritualism Three Patch Podcast Episode 112 (Un)Dead of Winter. Podcast segment retrieved from https://www.three-patch.com/casefiles//112-ACD

In 2011, Chris Wall, an HVAC technician at a Baxter Healthcare manufacturing site in North Carolina inspected the HEPA filters in a room where sterile Saline IV Bags were filled. He found them to be contaminated with mold. Management stopped him from changing them for 2 years, until he finally reached for help to the FDA. The result was a warning letter and 18 million dollar fine. In this episode, Diane and I meet with Tony Lee of AT Analytical (http://www.atanalytical.com/) to discuss the 2013 incident of mold contamination, and how to prevent mold contamination and ensure customer safety.   

Today on the Show: Did Russia pay to have the Taliban kill American GI's or maybe not? New York rep, Alexandria Ocasio-Cortez spearheads a letter, warning Israel not to annex some 30% of the West Bank or face possible financial sanctions. And more Billionaires getting rich on the COVID pandemic. The post AOC Spearheads Warning Letter to Israel appeared first on KPFA.

Pharmaceutical industry water system observation s

Details of the warning letter

This an introductory episode of Pharma GMP news updates from various websites, articles and magazines.

2nd Corinthians: A Look at The Human Side of PaulTherefore, if anyone is in Christ, he is a new creation. The old has passed away; behold, the new has come.2nd Corinthians 5:18 Before we get too far in, I should explain that there were at least three letters written by Paul, with some help from Timothy, to the Corinthians. Perhaps even four. You could point out that there are only two in the New Testament, and that is correct. But it appears that the missing two are in both 1st Corinthians and 2ndCorinthians. So while this might seem a bit odd, it happened in other books of the New Testament as well, notably Philippians. While many will speculate why did this happen, I think that is the wrong way to look at these books, especially 2nd Corinthians. What the combining of these letters did was to create for us a very human Paul,  who appears both saddened and joyful, in 2nd Corinthians. To me, this is the bigger story of 2nd Corinthians. But for those who are curious, here are the four letters in order of authorship. ·      Warning Letter; written to the Corinthians to caution them about sexual Immorality; referenced in chapter 5:9 of 1st Corinthians. ·      Actual 1st Corinthians·      Letter of Tears; written pre 2nd Corinthians, but referenced in Chapters 2:3-4 and it appears to be included in Chapters 10-13 of 2nd Corinthians.·      2nd CorinthiansThe reason this is important, is we get the full range of Paul's emotions. After the writing of 1stCorinthians, which was intended to get the church back on track, more drama arose.  Paul visited the church in Corinth, prior to the writing of 2nd Corinthians, to resolve these new issues.  In this book, he referred to this as his painful visit. Spurred on by outsiders, his Apostleship and teachings were challenged, leaving him hurt and dismayed. Prompting him to write the letter of tears; which in part is included in chapters 10-13 of 2ndCorinthians. 

The IRS sent a recent round of letters to cryptocurrency investors regarding their reporting obligations. Tim Speiss, Co-Leader of EisnerAmper’s Personal Wealth Group, discusses why someone would receive a warning letter, what they should do, penalties for failing to report, and the long-term tax outlook of cryptocurrency investment.

The IRS issued approximately 10,000 letters to warn U.S. crypto holders of remaining in compliance with tax code. Three variations of the letter were sent - 6173, 6174 and 6174-A. One asked for a signature of declaration of compliance under penalty of perjury. This letter was the milder warning version 6174-A. The point is, the IRS has its eyes on crypto users! https://www.wsj.com/articles/irs-sending-warning-letters-to-more-than-10-000-cryptocurrency-holders-11564159523 https://www.theverge.com/2018/2/26/17055264/coinbase-cryptocurrency-tax-irs-compliance-court-order Video version: https://youtu.be/70xqgJnkyGA - - - Video from the Amazing Space YouTube channel: https://www.youtube.com/watch?v=CyExswc5j7U This video was recorded by the SELENE Lunar Orbiter - images are copyright JAXA / NHK SELENE , better known in Japan by its nickname Kaguya, was the second Japanese lunar orbiter spacecraft following the Hiten probe] Music by: Sirius Beat - The Cosmos Link: http://youtu.be/Bkg08NvtvBU - - - Tips are welcome! Particl: SPH1WAYtbWSLsXvnoNWoUTwRKDqkXEay9iHVcwfsj7pTvKwobBY4SgAcKJGoFXXRArV2Fvcnug6aBEbDjsXEvM19P86uV7oi5qbjzz Bitcoin: 1GXgFVuXFBcdYiw23EsRyLHRqBxnU2FKUj - - - Find me elsewhere: https://desi-rae.com http://justthinkingoutloud.tv/watch

The IRS issued approximately 10,000 letters to warn U.S. crypto holders of remaining in compliance with tax code. Three variations of the letter were sent – 6173, 6174 and 6174-A. One asked for a signature of declaration of compliance under penalty of perjury. This letter was the milder warning version 6174-A. The point is, the... Read More » The post What the IRS Warning Letter Looks Like appeared first on ⋆ Crypto Ramble ⋆.

The FDA recently went after VIVUS, a pharmaceutical company, for making false health claims about its product. Inappropriate drug promotions can pose serious issues for pharmaceutical companies that go beyond superficial penalties--companies can face multibillion dollar fines as a consequence of making false claims about their products.

In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue our discussion of a recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around the timeline for the communication with the agency, types of 483s involved, definition of non-binding, what happens if a manufacturer ignores the FDA recommendation, and the most important takeaways from the guidance. Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

In the first part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around what this guidance is, what’s new about it, and whether or not it’s actually something we need. Specifically, we address a number of questions, including:What’s lead to this new guidance? Do we really need it?Why is FDA doing more inspections?What is the goal of this guidance/program?What is the difference between Form 483 and Warning Letter?What is the process described in this guidance?What does FDA respond with?Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at sfenske@rodmanmedia.com so I can consider discussing them with Mike in an upcoming episode. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Fluoride Is a Neurotoxin and an Endocrine Disrupting Drug that weakens bones and there is no known physiological requirement for Fluoride in water or anything else. When the government tells you it is safe, and then prevents you from purchasing it over the counter, stating that it is a drug, and only your doctor can prescribe it, something is terribly revealing here. Because of fluoride's toxicity, you cannot purchase fluoride "supplements" over-the-counter; they can only be dispensed by prescription under the supervision of a doctor. In short, sodium fluoride is not a nutritional "supplement;" it is a prescription drug, and a dangerous one. The FDA made this stunning declaration in a Warning Letter, in which the Agency called on a manufacturer to immediately cease selling fluoride drops and tablets. Removing harmful fluoride drugs from the market will protect the health of millions of children, but we also need to address the big elephant in the room: water fluoridation. TUNE IN WEDNESDAY MARCH 13 AT 7PM  FOR THE REST OF THE STORY

Does the issue of multiple observations to a plant site by the US drug regulator USFDA mean it will get a Warning Letter? Why is it that some companies that are issued just a few observations get Import Alerts? Why do some companies take years to solve USFDA regulatory problems? Does India face a ‘culture' problem when it comes to lack of compliance? Amit Rajan, an expert on quality and compliance issues, answers these and many more questions on a critical part of the operations of pharma companies in this week's podcast. He breaks down the basics of Form 483s, EIRs and the FDA. Tune in!

Hey Medicare Nation! How many of you have just found out your Doctor is leaving the Medicare Advantage Network you're in? I'm certain there are "Thousands of you." That is the #1 complaint I receive from clients, is that their "Doctor" is leaving or has left their Medicare Advantage Plan (MAPD) Network. Medicare has regulations about how a Medicare Advantage Organization (MAO) can "terminate" a Doctor contracted in their network and in reverse, there are regulations on how a Doctor can leave a MAO. There are also regulations on how a MAO publishes it's "Provider Directory" for their network. Chapter 4, Section 110.1.1 of the Medicare Managed Care Manual, titled, Provider Network Standards, lists in part....  "MAO's are required to establish and maintain provider networks that: ...... Are accurately reflected in up-to-date directories. Plans are responsible for verifying and regularly updating their network directories to ensure that providers included in the directories are available to their enrollees (ie, listed providers accept new patients who are enrolled in the plan).   In section 110.2.2 labeled Provider Directory Updates, it states in part: ....MAO's must include information regarding all contracted network providers in directories at the time of enrollment. Directories must include information about the number, mix, and distribution of all network providers. MAO's may have separate directories for each geographic area they serve (e.g. metropolitan areas, surrounding county areas), provided that all directories together cover the entire service area. Provider Directories must be updated anytime the MAO becomes aware of changes. They have 30 days to update the changes or be non-compliant. When there is a change to the provider network (a provider is terminated or the provider is leaving the network), The MAO "must make a good faith effort to provide a written notice of a termination of a contracted provider at least 30 calendar days before the termination effective date to all enrollees who are patients seen on a regular basis by the provider whose contract is terminating." In regards to termination of "Primary Care Physicians," all enrollees who are patients of that primary care professional must be notified."   So.....what's being done about all the inaccuracies to provider directories?   CMS conducted it's first review of 54 Medicare Advantage Organizations (MAO's) online provider directories, between February and August of 2016. The finding......45% of provider directory locations listed in these online directories were inaccurate! About one-third of all MAO's with 5,832 providers were reviewed in total. Twenty-One MAO's received warning letters from CMS around January 6th, and they have 30 days to fix the errors or face possible fines or sanctions, which could include suspending marketing and enrollment of medicare beneficiaries. Here are the Medicare Advantage Plans that received warning letters from CMS to immediately fix the errors in their provider directories. Blue Cross & Blue Shield of Rhode Island - RI Rhode IslandBlue Cross Blue Shield of Michigan - FL MI, MO WI Catholic Health Partners - IA,KY, MI, OH CIGNA  - IL, IA Community Health Plan of Washington - WA Emblem Health Inc. - CT, NY, RI Fallon Community Health - MA Gateway Health Plan, LP - OH, PA, WV Health Partners Plans, Inc. - PA Highmark Health - PA Humana Inc. - WI Indiana University Health - IA Magellan Health Inc. - NY Moda, Inc. AK, ID, MT, NM, OR, WA Molina Healthcare, Inc. - UT Piedmont Community Health Plan - VA Premera - WA Samaritan Health Services - OR SCAN Health Plan - CA UnitedHealth Group, Inc. - CO Wellcare Health Plans - IL   Now.... if you are a member of one of these MAO plans that received a "warning letter," you may qualify for a "Special Enrollment Period," from Medicare. What should you do?........ 1. Call Medicare - 800-633-4227 2. Tell the Medicare employee that you are a member of the ________ Medicare Advantage Plan, that received a "Warning Letter" from CMS for non-compliance of their provider directory. 3. State (if it's true!) that you were not notified by your physician or the MAO of the termination of your doctor, and your directory wasn't updated. 4. VERY IMPORTANT  TO STATE.....     Tell the Medicare employee you RELY on the directory to locate an in-network provider, and by the Medicare Advantage Plan & the Doctor NOT informing you that he/she was LEAVING the network, it caused a SIGNIFICANT access to care barrier for you!  Because now...... You can't see your doctor who has taken such good care of you..... due to the error. 5. Ask for a Special Election Period, so that you can choose a Medicare Advantage Plan where your Doctor is in-network. 6. If they grant you the Special Election Period, tell the Medicare employee which Medicare Advantage Plan you want to be on. 7. If they say "NO,"  Thank the Medicare Representative for their help and say goodbye.   What do you do now???? See if you qualify for a different Special Election Period. Listen to my earlier episode on SEP's. Listen to Last Friday's episode on 5 STAR Plans. Listen to the episode on the Medicare Advantage Disenrollment Period. It also includes information on Special Need Plans. If NONE of these ideas offer you the opportunity to change your Medicare Advantage Plan to a better option, than you will have to remain on the Medicare Advantage Plan you are on until the Annual Enrollment Period to change plans. Do your Due Dilligence Nation! Don't enroll in another Medicare Advantage Plan.... just because the doctor who is leaving the network is on that one! Make sure the plan will fit your Medical, financial and prescription needs for 2017! Share Medicare Nation with someone! Teach your parents, your grandparents how to access this podcast! Buy them a smartphone. The more they know, the less they will ask you for help. It's not easy being the "Sandwich Generation." So...... do yourself and your parents a favor and help them listen to Medicare Nation!