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 ...
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...
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 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, ...
"Autism detox" treatments, which include minerals like zeolite, are rising in popularity for promising to treat or reverse the diagnosis. Experts warn there is no science behind these claims.
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
Amid a deluge of executive actions, the Trump administration has directed federal health agencies to pause external ...
Agency cites contamination at Massachusetts plant where company makes ingredients used to produce various medicines ...
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