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  1. Enforcement Activities | FDA

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

These letters are supplied by the CDER Freedom of Information Office. This page only covers Office of Prescription Drug Promotion and CDER Headquarters warning letters. For district office warning letters, see the Main FDA FOI Warning Letters Page.

The agency redacted or edited some of the letters to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.  

"Cyber" letters are sent electronically via the Internet to web sites that offer to sell online prescription drugs that may be illegal.  The letters warn these web site operators that they may be engaged in illegal activities and informs them of the laws that govern prescription drug sales.  

Submit an FOI Request

If you want additional information on the status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Send FDA inquiries to: 

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857

Instructions for how to submit an FOI request are on the FDA Freedom of Information (FOI) Page.

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