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
• Advanced Search

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 10, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 13, 2009	Smith County Memorial Hospital	Dallas District Office	Mammography Quality Standards	Not Issued *
September 28, 2009	Zanzibar Cafe, Inc.	Los Angeles District Office	Seafood HACCP	Not Issued *
August 05, 2009	Gusto Food, Inc.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated	N/A *
November 03, 2009	Gibson Laboratories Inc	Cincinnati District Office	CGMP for Medical Devices/QS/Adulterated	Not Issued *
October 28, 2009	Double V Dairy	Seattle District Office	Animal Sale for Slaughter as Food/Adulterated	Not Issued *
September 23, 2009	Platinum Strategies, Inc.	Detroit District Office	Labeling/Promotional Claims False & Misleading/New Drug/Misbranded	Not Issued *

Posted on November 06, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
November 02, 2009	Lim Sin Wei	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
November 02, 2009	Han, Jeffrey	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
November 03, 2009	Algisiya Servicesz Limited	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
November 03, 2009	H.J. Bailey Co.	Center for Tobacco Products	Tobacco Products/Adulterated	Not Issued *
November 02, 2009	Li Ning	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Heavenly Smoke Inc	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Chavez, Inc.	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Clove Cigarettes Shop	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Texas Wholesale	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Euro-Cigs	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Amsterdam Tobacco Co	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Durango Smoke Shop, Inc.	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 03, 2009	Rokok Zone	Center for Tobacco Products	Tobacco Products/Adulterated/Misbranded	Not Issued *
November 02, 2009	Smoke Shop USA Ltd	Center for Tobacco Products	Tobacco Products/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