Federal regulators have warned a Waco, Texas, company that its human amniotic products are “unlicensed” and “unapproved,” and ...

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 ...

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, ...

As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...

The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current ...

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 ...

An injectable blood pressure drug has been recalled after the FDA has warned it could cause side effects, such as stroke or death.

The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in ...

"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.