FDA warning letters, December 2025

FDA posted 72 warning letters in December 2025. By issuing office: Center for Drug Evaluation and Research (CDER) 22; Center for Tobacco Products 18; Center for Devices and Radiological Health 14; Human Foods Program 7; Office of Compliance and Biologics Quality 3; and others. Each row gives the agency's own subject line and links to the letter.

Where this comes from

FDA publishes the warning letters it sends. Each row is one letter as the agency posted it: the company it is addressed to, the date on the letter, the date FDA posted it, the office that issued it and the agency's own subject line, with a link to the full letter. A warning letter states the agency's findings at the time it was written; it is not a final determination, and the company may have responded or since corrected the matter. Read the letter, and any response or close-out letter FDA has posted, before relying on it.

All monthsFDA device clearances