Inspections, Compliance, Enforcement, and Criminal Investigations
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
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.
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 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
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