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Warning Letters
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All Warning Letters posted prior to June 25th, 2001 are in PDF format. Warning Letters posted after June 25, 2001 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 recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular Warning Letter on this Web site, please contact the Agency. 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 on our Web site: How to Make a FOIA Request.
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| June 26, 2009 | Gordon, Mark, M.D. | Center for Drug Evaluation and Research | Clinical Investigator |
| June 25, 2009 | Chesterfield Dairy | Cincinnati District Office | Animal Sale for Slaughter as Food/Adulterated |
| June 16, 2009 | Zosa, Noli R., M.D. | Center for Drug Evaluation and Research | Clinical Investigator |
| June 15, 2009 | Dennis Paper and Food Service | New England District Office | Seafood HACCP/CGMP for Foods/Adulterated |
| June 10, 2009 | Inditherm Medical | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| June 05, 2009 | The South Bend Chocolate Company, Inc. | Detroit District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded |
| April 10, 2009 | Puretone Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation |
| March 02, 2009 | Cote, Charles J., MD | Center for Drug Evaluation and Research | Clinical Investigator |
| December 30, 2008 | Dongkuk Techco Rubber Ind. Sdn Bhd | Center for Devices and Radiological Health | CGMP/QSR/Adulterated |
| October 02, 2008 | Madespa S.A. | Center for Devices and Radiological Health | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated |
| August 21, 2008 | Brede, Inc. | Detroit District Office | CGMP/Deviations For Food Manufacturers/Adulterated |
| August 08, 2008 | Allez Spine, LLC | Los Angeles District Office | CGMP/QSR/Medical Devices/Adulterated |
| May 16, 2008 | Western United Fish Company, Inc. | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated |
| February 12, 2008 | Michael S. Miller, D.O. | Center for Biologics Evaluation and Research | Investigational Device Exemptions (Clinical Investigator) |
| January 07, 2008 | Reed's Compounding Pharmacy | Los Angeles District Office | New Drug/False Misleading/Labeling/Misbranded |
| January 07, 2008 | Pacifica Pharmacy | Los Angeles District Office | New Drug/False Misleading/Labeling/Misbranded |
| January 07, 2008 | Village Compounding Pharmacy | Dallas District Office | New Drug/False Misleading/Labeling/Misbranded |
| November 01, 2007 | Troy Innovative Instruments, Inc. | Cincinnati District Office | CGMP for Medical Devices/QS/Adulterated |
| October 30, 2007 | Chung's Products, LP | Dallas District Office | Seafood HACCP/Adulterated |
| September 11, 2007 | Tembec, Inc. | Cincinnati District Office | Food Additive/Adulterated/Misbranded |
| August 28, 2007 | Leiner Health Products, LLC | Atlanta District Office | CGMP for Finished Pharmaceuticals/Deviations/Adulterated |
| August 21, 2007 | Beef Northwest Feeders, LLC | Seattle District Office | Animals for Sale for Slaughter as Food/Adulterated |
| August 17, 2007 | Hain Celestial Group, Inc. | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| June 26, 2007 | Preferred Freezer Services, Inc. | New Jersey District Office | Seafood HACCP/Adulterated |
| March 02, 2007 | North American Medical Corporation | Atlanta District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| February 01, 2007 | Patient Advocacy Council, Inc. | Center for Biologics Evaluation and Research | Institutional Review Board |
| January 09, 2007 | Advanced Reproductive Laboratory | Dallas District Office | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products |
| November 27, 2006 | Health Dimensions, Inc. | Detroit District Office | Pharmacy Compounding/New Drug/Misbranded |
| December 19, 2005 | Tidman, Raymond E., M.D. | Center for Drug Evaluation and Research | Clinical Investigator |
| November 21, 2005 | Revival Animal Health, Inc. | Kansas City District Office | Promotional Claims False & Misleading/Adulterated/Misbranded |
| March 07, 2005 | Rapid Recovery Health Services Inc. | Center for Devices and Radiological Health | Lacks Premarket Approval/Adulterated/Misbranded |
| May 03, 2004 | Peak Performance Foods, LLC | Cincinnati District Office | Food Labeling/Misbranded |
| April 05, 2004 | Electro Therapeutic Devices, Inc. | Center for Devices and Radiological Health | QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated |