Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...

Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat, which was rejected by the agency last week. The letter – addressed ...

A Houston-based compounding pharmacy that was recently roped into Eli Lilly’s fight against knockoff GLP-1s has landed in the ...

In January, the FDA released a warning letter about a new canine allergy drug called Zenrelia. The letter updated safety ...

DexCom DXCM received a warning letter from the FDA on March 4, 2025, following inspections of its San Diego and Mesa facilities in 2024. The FDA cited deficiencies in the company’s manufacturing ...

The Food and Drug Administration sent a warning letter in early April to ICU Medical, alleging the company failed to submit premarket notifications for changes to infusion pumps. FDA inspectors ...