FiercePharma8d
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 ...
Food Safety News2d
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 ...
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 ...
Yahoo Finance13d
Hologic receives FDA warning letter over Biozorb implantable markers
Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...
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 ...
Undercurrent News5d
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 News12d
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 ...
Marlborough device maker receives FDA warning regarding implantable devices
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year.