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 ...

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 ...

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

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

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 ...

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, ...

The U.S. Food and Drug Administration has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.