DEAR MISS MANNERS: I work in an upscale office building in the downtown core. Our building is supposed to be solicitor-free, ...

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 ...

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs. FDA’s Center for Drug Evaluation ...

To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. A warning letter posted Tuesday by the Food and Drug Administration revealed quality control issues with ...

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last week citing issues at two of its manufacturing facilities. The warning ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous glucose monitor maker’s facilities last year. In a filing with the ...

DexCom DXCM-0.98%decrease; red down pointing triangle received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is ...