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 September 11, 2012
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
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September 07, 2012 | Lancome | Center for Food Safety and Applied Nutrition | New Drug Application [NDA] | Not Issued * |
September 07, 2012 | Greek Island Labs | Center for Food Safety and Applied Nutrition | New Drug Application [NDA] | Not Issued * |
September 05, 2012 | MDK Enterprises, Inc dba Maui Jelly Factory | San Francisco District Office | Acidified Foods/Adulterated | Not Issued * |
September 05, 2012 | Yangpo Foods Co.,Ltd. | Center for Food Safety and Applied Nutrition | Seafood HACCP/Adulterated | Not Issued * |
September 05, 2012 | Trans-Pacific Assets Management Inc. | San Francisco District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
August 30, 2012 | Fresh Mushroom Farm Inc | Kansas City District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
August 28, 2012 | Regeneca, Inc | Los Angeles District Office | Dietary Supplement/Adulterated | Not Issued * |
August 28, 2012 | Wendell Corporation dba Regalo Bakery | San Francisco District Office | CGMP Regulation for Foods/Adulterated | Not Issued * |
August 23, 2012 | bioMerieux, Inc. | Atlanta District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
August 22, 2012 | Global Biotechnologies, Inc. | New England District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
August 22, 2012 | CoffeeCigarette.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | Not Issued * |
August 16, 2012 | TCM Supply Corporation | Los Angeles District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
August 15, 2012 | Generic Medical Devices, Inc. | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
August 08, 2012 | Kimberly-Clark Corporation | Atlanta District Office | Devices/Misbranded | Not Issued * |
August 02, 2012 | Henrys Farm Inc. | Baltimore District Office | Insanitary Conditions/Adulterated | Not Issued * |
August 01, 2012 | Chu Minh Corp dba Chu Minh Tofu | Seattle District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
June 28, 2012 | Apia Enterprise Inc | Los Angeles District Office | Medical Device Reporting/Misbranded | 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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