Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.

Integra LifeSciences Holdings Corp. defeated investor allegations that the regenerative tissue company misrepresented its ...

AACE pharmaceuticals was slammed in a warning letter by the FDA that cited significant violations by its contract manufacturer Brassica Pharma, including sanitary conditions and made up lab records.

The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...

DexCom explained that it has "already submitted several responses to the Form 483 and is in the process of preparing a written response to the warning letter." It added that it plans "to continue ...

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following inspections of its two key manufacturing facilities, sending its shares down ...

DexCom DXCM 0.43% 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 ...