As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging ...

Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...

U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder ...

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 ...

The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and identified concerns in manufacturing processes and quality management.

The warning letter did not identify any new observations that had not already been provided in the Form 483s previously issued to the company by the FDA at the conclusion of its three inspections ...

The FDA responded to questions with a statement that didn’t address the publication of warning letters. The agency “remains fully committed to transparency, accountability, and the protection ...