Inspections, Compliance, Enforcement, and Criminal Investigations
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Warning Letters
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Recently Posted | 2013 | 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 February 14, 2013
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
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February 11, 2013 | Oasis Consumer Healthcare, LLC | Center for Drug Evaluation and Research | Unapproved products related to the 2012/2013 flu Season | Not Issued * |
February 11, 2013 | Discount Online Pharmacy | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
February 11, 2013 | Supplementality LLC | Center for Food Safety and Applied Nutrition | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
February 11, 2013 | Sun Drug Store | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
February 11, 2013 | Secure Medical Inc | Center for Drug Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
February 11, 2013 | Medsnoscript | Center for Drug Evaluation and Research | Unapproved products related to the 2012/2013 flu Season | Not Issued * |
February 11, 2013 | Vitalmax Vitamins | Center for Food Safety and Applied Nutrition | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
February 11, 2013 | Kosher Vitamin Express | Center for Food Safety and Applied Nutrition | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
February 07, 2013 | University of Berkley | Center for Biologics Evaluation and Research | Unapproved Products Related to the 2012/2013 Flu Season | Not Issued * |
February 06, 2013 | Genesis Herb Company LLC | Cincinnati District Office | CGMP/Dietary Supplements/Adulterated/Misbranded | Not Issued * |
February 05, 2013 | Futrex Incorporated | Baltimore District Office | Premarket Approval/Adulterated | Not Issued * |
February 04, 2013 | Millane Dairy | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
February 01, 2013 | Singing River Hospital System IRB | Center for Drug Evaluation and Research | Institutional Review Board (IRB) | Not Issued * |
January 31, 2013 | W. H. Walker Sons Inc | New York District Office | Juice/HACCP/Misbranded | Not Issued * |
January 29, 2013 | M.D.R. Fitness Corp. | Florida District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
January 29, 2013 | M circle M Canning Co. | Dallas District Office | CGMP/Acidified Foods/Adulterated | Not Issued * |
January 29, 2013 | P.A. Benjamin Manufacturing Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
January 29, 2013 | Sovereign Pharmaceuticals, LLC | Dallas District Office | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
January 28, 2013 | Bacterin International, Inc. | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
January 28, 2013 | Bacterin International, Inc. | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
January 25, 2013 | SciLabs Nutraceuticals | Los Angeles District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
January 23, 2013 | Gills Onions, LLC | Los Angeles District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
January 23, 2013 | ASI Medical, Inc. | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Not Issued * |
January 16, 2013 | CFS Dental, Inc | Florida District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
January 16, 2013 | North Star Dairy | Dallas District Office | Illegal Drug Residue | Not Issued * |
January 10, 2013 | Consolidated Marketing Unlimited, Inc. | Florida District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
December 04, 2012 | USPlabs, LLC | Dallas District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
November 02, 2012 | Rigid FX Orthopedics, Inc | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
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