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Inspections, Compliance, Enforcement, and Criminal Investigations

Warning Letters

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Ways to View/Browse Warning Letters

 

To view Warning Letters by date:

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:

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

     


    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 *
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Contact Us

  • Dockets Management

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  • Fax: 301-827-6870
  • Division of Dockets Management

    Food and Drug Administration

    5630 Fishers Lane

    Room 1061, HFA-305

    Rockville, MD 20852

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