Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationFDA and global regulatory affairs, consumer health, and professional development
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Major Eye Drop Recall Shows Manufacturing and Inspection Issues
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
Merit Medical Dialysis Catheter Recall – Risk of Serious Injury
Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer Design Defect May Lead to Hemorrhage, Embolization, and Loss of Vascular Access The U.S. Food and Drug Administration (FDA) has identified a Class I recall involving Merit Medical’s 16F Dual-Valved...
Blaine Labs Recalls Wound Care Gels for Microbial Contamination
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination Potential infection risk for vulnerable patients highlights critical quality system considerations Recall Overview Blaine Labs, Inc. has issued a voluntary...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New Pathway in Stroke Recovery A company behind one of the world’s most closely watched neurorehabilitation technologies is preparing for a major new...
FDA Warning Letter Cites Systemic Aseptic Manufacturing Failures
Medline Warning Letter Signals Systemic Quality Failures in Cardiovascular Device Manufacturing The FDA has issued a Warning Letter to Medline Industries (NAMIC Division) following a December 2025 inspection, identifying significant Quality System Regulation (QSR)...
FDA Approves First Gene Therapy for Genetic Hearing Loss
FDA Approves First Gene Therapy for Genetic Hearing LossRapid Review and Breakthrough Science Converge in Landmark OTOF Therapy The FDA has approved Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss caused by mutations in...
April 2026 Update for FDA QMSR Inspection Results
April 2026 Update for FDA QMSR Inspection ResultsConfirming the Shift to System-Level, Risk-Based Inspection When FDA’s Quality Management System Regulation (QMSR) took effect on February 2, 2026, the regulatory framework became formally aligned with ISO 13485. What...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
Warning Letter Cites Serious Deficiencies at Pharma Facility
Serious Sterility and CGMP Deficiencies at ProRx Outsourcing Facility The FDA has issued a significant Warning Letter to ProRx LLC, an FDA-registered outsourcing facility located in Exton, Pennsylvania, citing major violations involving sterile drug compounding...
FDA Cites Data Integrity and OOS Failures at Intas Pharma
FDA Warning Letter: Data Integrity and OOS Failures at Intas Pharmaceuticals Limited The U.S. Food and Drug Administration issued a Warning Letter to Intas Pharmaceuticals Limited citing significant violations of Current Good Manufacturing Practice (CGMP) at its...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
FDA Approves First Veterinary Amlodipine for Feline Hypertension
The U.S. Food and Drug Administration has approved Amodip (amlodipine besylate) chewable tablets for the control of systemic hypertension in cats. This approval marks a regulatory milestone as the first FDA-approved amlodipine product for veterinary use and the second...
Revival Animal Health Recalls Canine Milk Replacers
Revival Animal Health Recalls Canine Milk Replacers Due to Variable Vitamin D Levels Revival Animal Health, LLC of Orange City, Iowa, has voluntarily recalled multiple lots of its Breeder’s Edge® Foster Care® Canine Milk Replacer and Shelter’s Choice® Canine Milk...
FDA Approves First Generic for Equine Gastric Ulcers
FDA Approves First Generic Omeprazole Paste for Gastric Ulcers in Horses The U.S. Food and Drug Administration has approved Gastrobim (omeprazole) oral paste, the first generic version of a widely used treatment for gastric ulcers in horses. Gastrobim is indicated for...
Elite Treats Recalls Chicken Chips for Dogs
Elite Treats Recalls Chicken Chips for Dogs Due to Salmonella Risk On February 24, 2026, Elite Treats, LLC. announced a recall of a single lot of Chicken Chips for Dogs due to potential contamination with Salmonella — a pathogen that poses risks to both animal and...
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
FDA Recalls “Sexual Enhancement” Supplements
FDA Recall Highlights Ongoing Risks of Adulterated “Sexual Enhancement” Supplements Pure Vitamins and Natural Supplements, LLC (Tampa, FL) has issued a voluntary nationwide recall of several honey-based dietary supplement products after FDA laboratory testing detected...
How the Moringa Outbreaks Could Have Been Prevented
How This Could Have Been Prevented: A Quality Systems Perspective An MDP Consumer and Industry Brief After multiple moringa-linked Salmonella events, one uncomfortable truth is now clear. Even under DSHEA, manufacturers can do far more to prevent microbial...
Now the Salmonella in Moringa Is Drug-Resistant
Now the Salmonella in Moringa Is Drug-Resistant. That Changes the Stakes. An MDP Consumer and Industry Brief Salmonella contamination is serious in any consumer product. But one of the most concerning developments in the latest moringa-related outbreak investigation...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange modern pharmacy hiding in plain sight. Brightly colored “energy shots.” “Herbal” sexual enhancement pills. Kratom capsules and concentrated...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
Good Brain Tonic recalled by Liquid Blenz due to botulism risk
Good Brain Tonic Recall: Liquid Blenz Removes Beverage Due to Botulism Risk FDA Issues Nationwide Alert for “Memory and Focus” Drink Liquid Blenz Corp. has issued a nationwide recall of its Good Brain Tonic beverage due to the potential risk of botulism, a rare but...
Gas Station Drugs: The Regulatory Wild West
Walk into enough gas stations, smoke shops or convenience stores in America and eventually you will encounter a strange...
Warning Letter Cites Serious Deficiencies at Pharma Facility
Serious Sterility and CGMP Deficiencies at ProRx Outsourcing Facility The FDA has issued a significant Warning Letter to...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New...
FDA Approves First Veterinary Amlodipine for Feline Hypertension
The U.S. Food and Drug Administration has approved Amodip (amlodipine besylate) chewable tablets for the control of...
FDA Cites Data Integrity and OOS Failures at Intas Pharma
FDA Warning Letter: Data Integrity and OOS Failures at Intas Pharmaceuticals Limited The U.S. Food and Drug Administration...
FDA Warning Letter Cites Systemic Aseptic Manufacturing Failures
Medline Warning Letter Signals Systemic Quality Failures in Cardiovascular Device Manufacturing The FDA has issued a...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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