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. For District Office warning
letters, please see the Main FDA FOI Warning Letters Page.
Some of the letters have been redacted or edited 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.
Recently FDA has begun issuing "cyber" letters, letters sent
electronically via the Internet, to web sites that offer to sell online prescription drugs
that may be illegal. The letters warn these website operators that they may be
engaged in illegal activities and informs them of the laws that govern prescription drug
sales. A Press Release dated Feb. 2,
2000 describes these "cyber" letters.
If you wish to obtain available additional information on the current 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. Inquiries to FDA should
be sent 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 can be
found on the FDA FOI Page.
The letters are arranged in chronological order by year and month. All letters
are in Adobe Acrobat (PDF) format [Adobe Acrobat download
Back to FOI
updated March 4, 2008