FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that 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 "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, ...
With 2024 ending, the FDA has tabulated more than 3,500 warning letters (as of mid-December) by a variety of federal offices, including the Office of Regulatory Affairs and the Center for Drug ...
The US Food and Drug Administration has issued a warning letter to French drugmaker ... previously received a Form 483 notice, which outlined preliminary concerns. The FDA has now deemed Sanofi’s ...
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Cipla shares in focus after Goa facility receives form 483 with one observation from USFDAFollowing the inspection, the facility received one observation in Form 483. Cipla assured that it ... to further regulatory action, including warning letters or import bans.
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
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 ...
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