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 16, 2012
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
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October 11, 2012 | Finca Cojobas, Inc. | San Juan District Office | PHS Act/Shell Egg Regulation/Adulterated | Not Issued * |
October 10, 2012 | PC Tan | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Not Issued * |
October 10, 2012 | Zian Medical, LLC | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Not Issued * |
October 10, 2012 | Nissei Precision Instruments (Suzhou) Co., Ltd | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
October 09, 2012 | Stat Rx USA | Atlanta District Office | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | Not Issued * |
October 09, 2012 | Alere San Diego, Inc. | Los Angeles District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
October 09, 2012 | Medical Device Resource Corp | San Francisco District Office | Premarket Approval/Misbranded/Adulterated | Not Issued * |
October 09, 2012 | SMT-Schilling Metalltechnik GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
October 05, 2012 | Avon Products, Inc. (U.S. Headquarters) | Center for Food Safety and Applied Nutrition | New Drug/Misbranded | Not Issued * |
October 05, 2012 | Bioque Technology | Center for Food Safety and Applied Nutrition | New Drug Application [NDA] | Not Issued * |
October 05, 2012 | Xiantao Rayxin Medical Products Co. Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
October 04, 2012 | Tropical Seafood | New Orleans District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
October 02, 2012 | AHN International Inc DBA Amazing Herbs Nutraceuticals | Atlanta District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
October 01, 2012 | Bernick's Registered Holsteins | Minneapolis District Office | Illegal Drug Residue | Not Issued * |
September 28, 2012 | James G. Cole, Inc. dba Maxam Nutraceutics | Seattle District Office | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated | Not Issued * |
September 28, 2012 | Pulse Health LLC | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | Not Issued * |
September 27, 2012 | Altura Food, Inc. | San Juan District Office | Juice HACCP/CGMP for Foods/Labeling/Misbranded | Not Issued * |
September 27, 2012 | Mid Pac Foods, Inc. | San Francisco District Office | Acidified Foods/CGMP Regulations/Adulterated | Not Issued * |
September 26, 2012 | Natures One Inc | Center for Food Safety and Applied Nutrition | Food Labeling/Misbranded | Not Issued * |
September 26, 2012 | Lime Essentials | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Not Issued * |
September 25, 2012 | Copious International, Inc | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | Not Issued * |
September 25, 2012 | V and L Dairy | Seattle District Office | Illegal Drug Residue | Not Issued * |
September 25, 2012 | Acu International | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | Not Issued * |
September 24, 2012 | Celltex Therapeutics Corporation | Center for Biologics Evaluation and Research | Human Cells, Tissues & Cellular Products | Not Issued * |
September 24, 2012 | Texas Applied Biomedical Services | Center for Biologics Evaluation and Research | IRB (Institutional Review Board) | Not Issued * |
September 12, 2012 | DMC Medical Technology & Manufacturing Co., Ltd. | Center for Devices and Radiological Health | Quality System Regulation for Medical Devices/Adulterated | Not Issued * |
September 11, 2012 | EPS Biotechnology Corp. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
September 11, 2012 | Roberts Ranch of Oklahoma LLC | Dallas District Office | Illegal Drug Residue | Not Issued * |
August 28, 2012 | Creation's Garden Natural Products, Inc. | Los Angeles District Office | CGMP/Dietary Supplement/Adulterated/Misbranded | Not Issued * |
April 10, 2012 | Pleasant View Farms, Inc | Philadelphia District Office | Illegal Drug Residue | 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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