Warning Letters

FDA Enforcement Report Index
The FDA Enforcement Report is published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency regulatory activities.

FDA Recalls & Safety Alerts
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order.

FDA Warning Letters
This page is designed to simplify the search for Warning Letters. Choose any of the five search categories (most recent, by company, by subject, by issuing office, by date) and view or download the Warning Letter.

FDA Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
These letters are supplied by the CDER Freedom of Information Office (FOI). This page only covers letters issued by the Division of Drug Marketing, Advertising, and Communications, and by Headquarters.

FDA/ORA Import Alerts
The purpose of an Import Alert is to identify and disseminate import information (problems, violative trends, etc.) to FDA personnel thus providing for more uniform and effective import coverage. Import Alerts identify problem commodities and/or shippers and provide guidance for import coverage.