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 ...
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 ...
Yahoo Finance14d
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 ...
FDA Inspections Seminar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection (ONLINE EVENT: February 24-25, 2025)
The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
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 ...
Dallas Morning News6d
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
The U.S. Food & Drug Administration sent a warning letter to Frontier Biologics in November, outlining concerns about the company’s operations. But Frontier Biologics chief scientist Gene ...
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 ...