As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its ...
She described her cousin's basement, garage and dorm as being an epicenter for drug use, where he would also put baby ...
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
The US Food and Drug Administration hit two foreign seafood processors and one Buffalo, New York-based seafood importer with warning letters this week ...
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, ...
Agency cites contamination at Massachusetts plant where company makes ingredients used to produce various medicines ...
On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility’s bioreactor, the vessel used to grow organisms and cells. According to ...
Caroline Kennedy, the cousin of Trump Health and Human Services Department nominee Robert F. Kennedy, Jr., has sent a letter ...