Glossary · FDA compliance
What is an FDA warning letter?
An FDA warning letter is a formal, public notice issued to a firm that FDA believes has significantly violated federal regulations, identifying the violations and requesting prompt corrective action.
FDA issues a warning letter when it determines a firm has committed significant violations — for example in manufacturing practice, labeling, data integrity, or marketing of an unapproved product. The letter names the firm, the violations, and a deadline (commonly 15 working days) to respond with corrections.
Warning letters are published on FDA's website and are official records. A letter that has not received a 'close-out' notice indicates the remediation matter may still be open — a live compliance window.
For compliance, quality-systems and consulting vendors, an open warning letter is a documented, dated reason a firm is in-market for help.
Source: US Food and Drug Administration.
FAQ
Common questions
Are FDA warning letters public?
Yes. FDA publishes warning letters on its website, including the firm, the cited violations, and the issue date.
What does 'close-out' mean for a warning letter?
A close-out letter is issued after FDA confirms a firm has corrected the cited violations. A warning letter without a close-out indicates the matter may still be open.
Turn it into leads
Related lead types
Related terms
Keep reading
Turn FDA warning letter into a lead feed
ParseData watches this record and alerts you when a new one appears — self-serve, observational, dated.