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 ...
FDA Warning Letter expands scope of FDA Form 483 The Warning Letter to Applied Therapeutics identified critical issues, specifically regarding dosing error, data integrity and protocol adherence ...
The FDA has slapped a warning letter on Sanofi’s Genzyme facility ... and yielded a Form 483, which the FDA says Sanofi responded to by late July. The letter itself, which marks an escalation ...
The warning letter did not identify any new observations that had not already been provided in the Form 483s previously issued to the company by the FDA at the conclusion of its three inspections ...
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 ...
Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...
Distributors received this warning letter directly from the FDA as well. According to the FDA, cookware made from aluminum, brass, and aluminum alloys known as Hindalium/Hindolium or Indalium ...
The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
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