Inspections, Compliance, Enforcement, and Criminal Investigations
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Warning Letters
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Recently Posted | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |
Tobacco Retailer Warning Letters
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Types of Warning Letters on the FDA Website
- General FDA Warning Letters
- Tobacco Retailer Warning Letters
- Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies)
Read more about types of warning letters
Topics on this Page:
- Ways to View/Browse Warning Letters
- More Information About Warning Letters Posted Here
- 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.
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Or:
- Perform an Advanced Search
- Use any of these "Browse" functions:
To download information about Warning Letters to an Excel document:
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Use the Search and Export Warning Letters to Excel function.
More Information about Warning Letters Posted Here
- 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 October 02, 2012
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
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September 21, 2012 | Janson-Beckett | Center for Food Safety and Applied Nutrition | New Drug Application [NDA] | Not Issued * |
September 21, 2012 | Andes Natural | Center for Food Safety and Applied Nutrition | New Drug Application [NDA] | Not Issued * |
September 18, 2012 | Grindstone Neck of Maine, LLC | New England District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
September 18, 2012 | Eyal Bar Oz | Center for Drug Evaluation and Research | Unapproved and Misbranded New Drugs | Not Issued * |
September 14, 2012 | EMG Manufacturing Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded | Not Issued * |
September 14, 2012 | Oregon Aesthetic Technologies, Inc. | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
September 12, 2012 | C.C. & Son Farms, Incorporated | San Francisco District Office | PHS Act/Violation/Adulterated | Not Issued * |
September 06, 2012 | Quzhou Chemsyn Pharm Co Ltd | Center for Drug Evaluation and Research | Failure to Register and List | Not Issued * |
September 05, 2012 | Petaluma Farms | San Francisco District Office | PHS Act/Shell Egg Regulation/Adulterated | Not Issued * |
August 27, 2012 | Cendano Corporation Ltd. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
August 22, 2012 | Cape Florida Seafood, Inc. | Florida District Office | Seafood HACCP/Adulterated | Not Issued * |
July 10, 2012 | The American Bottling Company, Inc. | Dallas District Office | Juice HACCP/Adulterated | Not Issued * |
April 06, 2012 | Upspring, Ltd | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded | Not Issued * |
December 19, 2011 | Satyaprakash N. Makam, MD | Center for Devices and Radiological Health | Investigational Review Board (IRB)/Medical Devices | Not Issued * |
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Contact FDA
301-827-6860
Fax:301-827-6870
Dockets Management
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061, HFA-305
Rockville, MD 20852
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