FiercePharma3h
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers whose active pharmaceutical ingredients (API) were previously shipped to the U.S. | The FDA ...
JD Supra27d
Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...
Food Safety News1d
FDA warns two companies over foreign supplier verification violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
The Pharma Letter4d
US FDA issues more warning letters to Asian producers
The US Food and Drug Administration (FDA) has issued several warning letters to pharmaceutical manufacturers in India and ...
Yahoo Finance26d
Hologic receives FDA warning letter over Biozorb implantable markers
Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...
Food Safety News8d
FDA warns seafood companies over HACCP violations and potentially adulterated products
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Amid recalls, Minnesota medtech exec says she was pressured to disregard safety law
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
Becker's Hospital Review23h
FDA warns of injury risk with catheter system
Bard Peripheral Vascular, a subsidiary of Becton, Dickinson and Co., has reported 30 serious injuries and four deaths linked to the device due to a potential risk of helix fractures or breakages ...
The Business Journals27d
Marlborough device maker receives FDA warning regarding implantable devices
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year. Hologic Inc. has ...
Becker's Hospital Review12d
FDA warns GLP-1 compounder over safety rules
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...