Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion and CDER Headquarters warning letters. 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.
Related Resources
All FDA Warning Letters
Search through all FDA Warning Letters.
About Warning and Close-Out Letters
This page reviews the types of warning letters found on the FDA website.
Archived CDER Warning Letters (1998-2014)
Freedom of Information (FOI)
Visit the FOI page for instructions on how to submit an FOI request or for more information on the status of an issue in a particular warning letter or notice of violation.