Warning Letters

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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

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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.

   

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  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.  

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  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.

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  Recently Posted Warning Letters

Posted on November 20, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 13, 2009	Allegis Pharmaceuticals, LLC	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Cornerstone BioPharma, Inc.	Atlanta District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Larken Laboratories	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Everett Laboratories, Inc	New Jersey District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Accentia Biopharmaceuticals, Inc	Florida District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Wraser Pharmaceuticals	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Zyber Pharmaceuticals, Inc	New Orleans District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Tiber Laboratories	Atlanta District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *
November 13, 2009	Victory Pharma Inc	Los Angeles District Office	Lacks Approved New Drug Application/Adulterated	Not Issued *

Posted on November 19, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 16, 2009	Eugene Lefter	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	William Wynne	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Ric Deleon	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	New Horizons LTD	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Akyuz, Sinan	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Chris Walsh, c/o Dynadot Privacy	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Krest Holdings, Panama S.A.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	onlinepharmacyy.com@proxy.dreamhost.com	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Xanos Holdings Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Med Light Ltd	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	tvforever	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Hunter, D	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Akyuz, Sinan	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Petroff, Andrey	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	BUZZ, LLC	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Forrest Media Incorporated	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Chen-Yu Ou	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Orion Star & Associates Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Randek l-warez	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Pro West Marketing Ltd.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Mendez, Dr Antonio	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
November 16, 2009	Lorna Hillier	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *

Posted on November 17, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 06, 2009	Eisai Medical Research, Inc.	Center for Drug Evaluation and Research	DDMAC/Promotional Claims False & Misleading/Misbranded	Not Issued *
June 08, 2009	DS Waters of America, LP	Center for Food Safety and Applied Nutrition	Misbranded/Labeling/Unauthoriz ed Health Claims	N/A *
November 09, 2009	Dallas Jr, Anthony V, MD	Center for Drug Evaluation and Research	Clinical Investigator	Not Issued *
August 05, 2009	Adon Farms	New York District Office	Animal Sale for Slaughter as Food/Adulterated	N/A *
October 29, 2009	Seoul Shik Poom Inc.	New Jersey District Office	Seafood HACCP/Misbranded	Not Issued *
September 09, 2009	Szarek, Francis J	New York District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
August 12, 2009	Abbott Molecular	Chicago District Office	CGMP/QSR/Medical Devices/Adulterated	N/A *
November 06, 2009	Dynamic Nutritional Associates	Seattle District Office	Labeling/False & Misleading Claims/Misbranded	Not Issued *
September 09, 2009	Lloyd T. Smith & Sons	New York District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
November 10, 2009	Arnold Tuber Industries Dba Sci-Dent, Inc	New York District Office	CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded	Not Issued *

* Not issued: 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.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters