Becker's Hospital Review23h
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, ...
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 ...
Acsh.org3d
FDA Warning Letter
The crisis is now over, but if you were a young family with babies three years ago, scary memories of escalating health worries and retail stores bereft of infant formulas remain.
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 ...
Becker's Hospital Review8d
FDA warns Sanofi over manufacturing violations
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, ...
Food Safety News4d
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 warns Sanofi of manufacturing irregularities at key facility
The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current ...
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 ...
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.
The Business Journals9d
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 ...
Wyoming News8d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
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.