Medical device distribution giant Medline was slammed for a second time since April by an FDA warning letter that chided the company for repeated problems centered on the presence of toxic bacteria in ...
Cdymax Pharma, the FDA said, has had about 1,500 lab incidents since 2023 that involved out-of-spec results and other significant analytical events such as equipment failures. (CQ-Roll Call/Getty ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...
The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing ...
A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not ...
The US Food and Drug Administration (FDA) recently issued two warning letters to manufacturers that sold microbially contaminated ophthalmic drug products linked to an ongoing investigation into a ...
Apex Compliance's Asa Waldstein outlined how recent FDA warning letters, lawsuits and advertising challenges can guide ...
A seafood company failed to follow federal safety rules to prevent potential botulism contamination. A business was hawking dietary supplements with the misleading claim that they’d cure, treat or ...
The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large infant botulism ...
On March 13, 2026, the Federal Trade Commission announced that it is sending warning letters to ninety-seven auto dealerships throughout the nation. The letters state, "[t]his letter is to advise you ...
The U.S. Food and Drug Administration has sent seven warning letters to companies that it says are illegally marketing products containing 7-hydroxymitragynine (7-OH), also known as synthetic ‘kratom’ ...
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