Novo Nordisk issued a response to an FDA warning letter that cited serious violations in how the company tracked and reported ...

Simtra BioPharma Solutions was issued a warning letter by the FDA after an inspection uncovered a number of problems at the ...

The agency cited 2 deaths and a case of suicidal ideation among incidents that were not submitted within required timeframes ...

In the warning letter, the FDA alleged that Novo inadequately responded to observations made after an inspection carried out across January and February of 2025.

Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report.

Novo Nordisk has responded to a "warning letter" which claims the pharmaceutical giant didn't report adverse side effects, or ...

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 ...

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

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 ...

Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week ...

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...