Warning Letters

Recently Posted| 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

Topics on this Page: 

• Ways to View/Browse Warning Letters
• Warning Letter Close-Out Letter Program (applies to letters issued on or after Sept. 1, 2009)
• More Information About Warning Letters
• Recently Posted Warning Letters

---

Sign Up to Receive Warning Letter Updates

---

Ways to View/Browse Warning Letters

 

To view Warning Letters by date:

• Review the list of recently posted warning letters below.

Or:

• Select the year from the list above in which the warning letter was issued, and browse the chronological list of warning letters on the linked page.

 

To find specific Warning Letters:

• Perform a simple search by entering criteria into the search box below.

 

 

• Or:

  • Perform an Advanced Search
  • Use any of these "Browse" functions:
    • Browse Warning Letters by Company
    • Browse Warning Letters by Issuing Office
    • Browse Warning Letters by Subject
    • Browse Warning Letters with Response Letters
    • Browse Warning Letters with Closeout Letters

• To download information about Warning Letters to an Excel document:

  • Use the Search and Export Warning Letters to Excel function.

   

  ---

  Warning Letter Close-Out Letter Program (applies to letters issued on or after Sept. 1, 2009)

  FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009. A close-out letter will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA. Usually, the standard for verifying that corrections have been implemented will be a follow-up inspection. If the Warning Letter contains violations that by their nature are not correctable, then no close-out letter will issue. Future FDA inspections and regulatory activities may further assess the adequacy and sustainability of these corrections. Should violations be observed during a subsequent inspection or through other means, enforcement action may be taken without further notice. The FDA office that issued the Warning Letter will issue the close-out letter, and that office may be contacted for information on a particular Warning Letter. Any questions about close-out letter process in general can be addressed to the Division of Compliance Policy at WLCloseOutProcess@fda.hhs.gov.  

  ---

  More Information about Warning Letters

  • Warning letters posted before June 25, 2001, are in PDF format. Warning letters posted after that date are available in HTML format.
  • Persons with disabilities having problems accessing PDF files may call 301-827-6567 for assistance.
  • Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
  • To obtain available additional information on the current status of an issue in a particular warning letter on this site, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.

  ---

  Recently Posted Warning Letters

Posted on February 09, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
February 02, 2010	Portal Pharmaceutical, Inc.	San Juan District Office	Labeling/New Drug Application	Not Issued *
January 28, 2010	Nasr, Samya, M.D.	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
January 26, 2010	Fertility and Reproductive Medicine Center for Women	Florida District Office	Human Cells, Tissues & Cellular Products	Not Issued *
January 25, 2010	Meyer Food Service LLC dba Empire Fish Co	Minneapolis District Office	Seafood HACCP/Adulterated	Not Issued *
January 19, 2010	Cayman Chemical Company	Center for Drug Evaluation and Research	Clinical Investigator (Sponsor)	Not Issued *
January 15, 2010	Baxter Biosciences	Center for Biologics Evaluation and Research	CGMP Deviations	Not Issued *

Posted on February 02, 2010

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
January 27, 2010	OST Medical, Inc.	New England District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
January 14, 2010	Premium Dental, LLC	New Jersey District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
December 21, 2009	Ohm Laboratories, Inc.	New York District Office	CGMP for Finished Pharmaceuticals/Adulterated/Misbranded	Not Issued *
November 06, 2009	ELA Medical S.A.S.	Center for Devices and Radiological Health	CGMP/QSR/Medical Device Reporting/Misbranded	Not Issued *
September 29, 2009	Millipore Corporation	Center for Devices and Radiological Health	Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus	Not Issued *

-