Drugs
A 3/9-3/16 FDA inspection at the TCI Co., Ltd BioCosme PABP Branch drug manufacturing facility in Taipei City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/2 Warning Letter says the four specific violations were: * failure to
Devices
After working on over 25 medical device Form FDA-483s and Warning Letters for clients this year, attorneys Jodi Scott and Mike Heyl (Hogan Lovells Cadwalader) say it is clear that FDA has changed its approach to inspections under the QMSR to focus on a “holistic evaluation of quality system
Drugs
FDA should strengthen its oversight and enforcement of confirmatory trials for accelerated approval drugs, with Medicare and Medicaid payments limited until the products’ clinical benefits are confirmed, according to a new proposal for expanding the agency's role in addressing drug costs. The proposal is one of several recommendations
Drugs
Recent FDA enforcement activities could signal increased scrutiny of telehealth platforms that facilitate prescribing of compounded drugs, particularly when technology or standardized processes may undermine individualized clinical decision-making, according to attorneys at ArentFox Schiff. In an 10/5 Insights post, attorneys Abha Kundi and Matthew Berlin noted FDA'
Drugs
FDA has cited Olympia Pharmaceuticals for eight observations involving aseptic processing, environmental monitoring, component testing and other manufacturing controls following an inspection last month at the company's Orlando, FL, outsourcing facility. The Form 483 said Olympia’s aseptic processing areas had deficiencies in environmental and personnel monitoring. Investigators
enforcement
FDA has cited Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification (OOS) potency results, finding that the company repeatedly attributed the failures to its contract testing laboratory and released most of the affected compounded drugs after retesting. The findings were detailed in a
enforcement
FDA has released the Form FDA-483 issued following a 6/8-6/17 inspection at XeCare, a New Albany, OH, producer of sterile and non-sterile drug products. The three inspection observations were: * producing hazardous drugs without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/
enforcement
Former FDA chief counsel Mark Raza has joined Hogan Lovells Cadwalader as senior counsel in its Pharmaceuticals and Biotechnology practice. Raza has more than 35 years of FDA experience, including service in the agency’s Office of Chief Counsel. He retired in 2025 after serving four years as chief counsel.
enforcement
FDA has cited Travere Therapeutics over promotional materials for Filspari (sparsentan) because they contain misleading claims about the drug’s ability to preserve kidney function and its safety profile. “Specifically, claims suggesting that patients treated with Filspari will achieve kidney preservation, preservation of kidney function, or nephroprotection are misleading because
enforcement
A 1/27-2/5 FDA inspection at the Fenwal International facility in Maricao, PR, documented evidence of significant deviations from current good manufacturing practice (CGMP) requirements applicable to the firm’s manufacture of blood pack units and component solutions intended for the collection and storage of whole blood and
enforcement
A 6/2-6/13/2025 FDA Bioresearch Monitoring Program inspection of a clinical trial conducted by Stephen Fallon in Wilton Manors, FL, found that Fallon violated regulations governing the proper conduct of clinical studies involving investigational products. An 8/27 Warning Letter says the specific violations were: * failure to
enforcement
CDRH has issued an early alert based on a Draeger letter to customers recommending certain VentStar Resus Neo hoses (breathing circuits) be removed from where they are used or sold. Draeger stated that they are aware of cases in which obvious cracks in the hose were detected by the users
enforcement
Senate Special Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) are asking the Government Accountability Office (GAO) to analyze the connection between foreign drug manufacturing and drug recalls. In their letter to the GAO, the senators said, “Over the past three decades, the
enforcement
A 4/13-4/17 FDA inspection at the Shoolin Pharma Chem drug manufacturing facility in Mehsana, Gujarat, India, found that the company manufactures active pharmaceutical ingredients (APIs) under insanitary conditions and with significant deviations from current good manufacturing practice (CGMP) regulations for APIs. An 8/18 Warning Letter says
enforcement
A 2/23-3/6 FDA inspection at Jabil Inc.’s Pharmaceutics International drug manufacturing facility in Cockeysville, MD, found significant violations of current good practice (CGMP) regulations for finished drugs. An 8/27 Warning Letter says the three specific violations were: * failure to thoroughly investigate any unexplained discrepancy or