The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...

The company based in Lexington County received its inspection report back from federal regulators. Here's what it showed.

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

Shares of Alvotech (NASDAQ: ALVO) fell 22% on Monday after the U.S. Food and Drug Administration (FDA) issued a Complete ...

The notice follows inspections of three Philips facilities that found failures to meet standards for reporting complaints and ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

The Food and Drug Administration has advanced an investigation into one Salmonella outbreak and declared another one over.

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in ...

The U.S. Food & Drug Administration has confirmed that the multistate outbreak of Listeriosis linked to refrigerated and ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...