What is a warning letter from the FDA?
Warning letters indicate violations of regulatory significance that could lead to enforcement actions if not promptly and adequately corrected. While they are not considered a final regulatory action by the FDA, they serve to establish prior notice.
Why Warning letters are issued?
A warning letter is issued by more senior FDA officials after they’ve reviewed the inspector’s report. A warning letter is considered an escalation from a 483 observation. The most common causes for an FDA warning letters are: Non-compliant written procedures.
These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion and CDER Headquarters Warning Letters.
All the Current warning letters can be accessed by clicking the link below