Class 1 recalls pose serious health risks, from undeclared allergens to bacterial contamination. Here’s how Class 1 recalls work, plus major FDA food recalls in 2025.
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
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, ...
She described her cousin's basement, garage and dorm as being an epicenter for drug use, where he would also put baby ...
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its ...
The FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice regulations for active pharmaceutical ingredients.
As a growing number of cats have gotten sick or died after consuming raw pet food or raw milk contaminated with the H5N1 virus, health officials have advised pet food companies to take extra ...
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 ...
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FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis casesThe US Food and Drug Administration (FDA) is adding the risk of anaphylaxis to a new boxed warning of glatiramer acetate, a ...
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