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, ...
Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in ...
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted ...
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
The US Food and Drug Administration (FDA) is warning about the risk of a rare but serious allergic reaction with the medicine ...
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