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2007 Warning Letters
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* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.
Read more about warning and close-out letters
Posted on July 07, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 27, 2007 | Mullet, Ivan | New York District Office | Illegal Drug Residue | N/A * |
December 27, 2007 | Absolutely Fresh Seafood Company | Kansas City District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
December 21, 2007 | Northwest Medical Physics Equipment, Inc. | Seattle District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
December 21, 2007 | Medical Device Resource Corporation | San Francisco District Office | Premarket Approval/Misbranded/Adulterated | N/A * |
December 21, 2007 | Cemac Foods Corporation | Philadelphia District Office | CGMP/Misbranded | N/A * |
December 21, 2007 | Ambassador Meat Distributors Inc | Kansas City District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
December 20, 2007 | Universal Enterprises Inc dba Air Service Hawaii | San Francisco District Office | Interstate Conveyance Sanitation Regulations/Provisional | N/A * |
December 19, 2007 | Abbott Vascular, Inc. | Center for Devices and Radiological Health | Medical Devices/Adulterated/Misbranded | N/A * |
December 18, 2007 | Keystone Food Products Inc | Philadelphia District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions | N/A * |
December 18, 2007 | P-Ryton Corporation | New York District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
December 17, 2007 | Siemens Medical Solutions, Ultrasound Division | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated | N/A * |
December 13, 2007 | Moisan Dairy | Seattle District Office | Illegal Drug Residue | N/A * |
December 13, 2007 | G. Dundas Company Inc | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | N/A * |
December 07, 2007 | Polychrome Medical, Inc | Minneapolis District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
December 07, 2007 | Spinal, USA | New Orleans District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded | N/A * |
December 05, 2007 | Wheatley, Susan J., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 04, 2007 | G.D. Mathews and Sons Corporation dba Mathews Salad House Food Products | New England District Office | Seafood HACCP/Adulterated | N/A * |
December 04, 2007 | Wild Edibles, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
December 04, 2007 | Wild Edibles, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | N/A * |
December 03, 2007 | Pacific Consolidated Industries LLC | Los Angeles District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated | N/A * |
November 30, 2007 | Barnacle Seafod, Inc. | Florida District Office | Seafood HAACP/CGMP for Foods/Adulterated | N/A * |
November 30, 2007 | Avicenna Laser Technology Inc | Florida District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
November 29, 2007 | E-Med Future, Inc. | Cincinnati District Office | Devices/Quality System Regulation | N/A * |
November 28, 2007 | Stryker Orthopaedics Corp. | New Jersey District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | N/A * |
November 28, 2007 | Precision Biometrics, Inc. | Center for Devices and Radiological Health | Device/Lacks Premarket Approval Application/Adulterated/Misbranded | N/A * |
November 26, 2007 | Glenn Foods, Inc. | Center for Food Safety and Applied Nutrition | Food Labeling Regulation | N/A * |
November 21, 2007 | GlaxoSmithKline | Center for Drug Evaluation and Research | Drug Labeling/Promotional Claims/Misbranded | N/A * |
November 21, 2007 | Venosan North America | Center for Devices and Radiological Health | Medical Device Reporting | N/A * |
November 19, 2007 | Winchester Bay Fisheries, LLC | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated | N/A * |
November 19, 2007 | Imperial Trading Company, Inc. | New Orleans District Office | CGMP For Manufacturing, Packing, or Holding Human Food | N/A * |
November 16, 2007 | GE Healthcare/General Electric Company | Minneapolis District Office | Devices/X-ray Equipment | N/A * |
November 16, 2007 | Ben Venue Laboratories, Inc. | Cincinnati District Office | CGMP/Deviations/Adulterated | N/A * |
November 16, 2007 | Custom Assemblies, Inc. | Atlanta District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded | N/A * |
November 14, 2007 | Simco Dairy | Seattle District Office | Illegal Drug Residue | N/A * |
November 14, 2007 | Visser Ranch | Denver District Office | Illegal Drug Residue | N/A * |
November 09, 2007 | Nurse Assist, Inc. | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated | N/A * |
November 07, 2007 | Marjon Specialty Food, Inc | Florida District Office | CGMP/Misbranded | N/A * |
November 07, 2007 | C.V. Indotropic Fishery | Center for Food Safety and Applied Nutrition | Seafood HACCP/Adulterated | N/A * |
November 07, 2007 | Amerifit Brands, Inc | New England District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded | N/A * |
November 06, 2007 | Ole' Mexican Foods, Inc. | Atlanta District Office | Promotional Claims False & Misleading/Misbranded | N/A * |
November 02, 2007 | Fisheries Research Laboratory- SIU-C | Center for Veterinary Medicine | GLP/Bioresearch Monitoring Program | N/A * |
November 01, 2007 | Troy Innovative Instruments, Inc. | Cincinnati District Office | CGMP for Medical Devices/QS/Adulterated | N/A * |
October 31, 2007 | Northeast General Pharmaceutical Factory | Center for Drug Evaluation and Research | Current Good Manufacturing Practice Regulation/Adulterated | N/A * |
October 31, 2007 | Belford Seafood Co-Op | New Jersey District Office | Seafood HACCP/CGMP for Foods/Adulterated | N/A * |
October 30, 2007 | VAN Oriental Food, Inc. | Dallas District Office | Seafood HACCP/Adulterated | N/A * |
October 30, 2007 | A La Carte Foods, Inc. | New Orleans District Office | CGMP for Foods/Seafood HACCP/Adulterated | N/A * |
October 30, 2007 | International Technidyne Corporation | New Jersey District Office | CGMP/QSR/Medical Device Reporting/Adulterated | N/A * |
October 30, 2007 | Cytosol Laboratories, Inc. | New England District Office | CGMP/Deviations/Adulterated | N/A * |
October 30, 2007 | Chung's Products, LP | Dallas District Office | Seafood HACCP/Adulterated | N/A * |
October 29, 2007 | VDS Farms, L.L.C. | Detroit District Office | Illegal Drug Residue | N/A * |
Contact FDA
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Food and Drug Administration
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Rockville, MD 20857