FiercePharma9d
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
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 ...
Becker's Hospital Review5h
FDA warns GLP-1 compounder over safety rules
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, ...
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
Food Safety News3d
FDA warns bakery for food safety violations, including sanitation and allergen control failures
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are ...
Caroline Kennedy calls cousin RFK Jr. a ‘predator’ in warning letter to senators
She described her cousin's basement, garage and dorm as being an epicenter for drug use, where he would also put baby ...
The Business Journals8d
Sanofi’s Framingham facility hit with FDA warning
French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham. French ...
Undercurrent News6d
FDA targets two foreign seafood processors, one US importer for HACCP violations
The US Food and Drug Administration hit two foreign seafood processors and one Buffalo, New York-based seafood importer with warning letters this week ...
Plastics News13d
FDA warns Hologic to do more to prevent harm from component in recalled implant markers
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...