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Inspections, Compliance, Enforcement, and Criminal Investigations
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2007 Warning Letters
Warning Letters for 2007
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| December 27, 2007 | Mullet, Ivan | New York District Office | Animals for Sale for Slaughter as Food/Adulterated |
| December 27, 2007 | Absolutely Fresh Seafood Company | Kansas City District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| December 21, 2007 | Northwest Medical Physics Equipment, Inc. | Seattle District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| December 21, 2007 | Cemac Foods Corporation | Philadelphia District Office | CGMP/Misbranded |
| December 21, 2007 | Medical Device Resource Corporation | San Francisco District Office | Premarket Approval/Misbranded/Adulterated |
| December 21, 2007 | Ambassador Meat Distributors Inc | Kansas City District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| December 20, 2007 | Universal Enterprises Inc dba Air Service Hawaii | San Francisco District Office | Interstate Conveyance Sanitation Regulations/Provisional |
| December 19, 2007 | Abbott Vascular, Inc. | Center for Devices and Radiological Health | Medical Devices/Adulterated/Misbranded |
| December 18, 2007 | P-Ryton Corporation | New York District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| December 18, 2007 | Keystone Food Products Inc | Philadelphia District Office | CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions |
| December 17, 2007 | Siemens Medical Solutions, Ultrasound Division | Center for Devices and Radiological Health | Premarket Approval/Misbranded/Adulterated |
| December 13, 2007 | Morton Grove Pharmaceuticals, Inc. | Center for Drug Evaluation and Research | DDMAC/Promotional Claims False & Misleading/Misbranded |
| December 13, 2007 | Moisan Dairy | Seattle District Office | Animal Sale for Slaughter as Food/Adulterated |
| December 13, 2007 | G. Dundas Company Inc | Seattle District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| December 10, 2007 | Wyeth Pharmaceuticals Inc. | Center for Drug Evaluation and Research | DDMAC/Promotional Claims False & Misleading/Misbranded |
| December 07, 2007 | Polychrome Medical, Inc | Minneapolis District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| December 07, 2007 | Spinal, USA | New Orleans District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded |
| December 05, 2007 | Wheatley, Susan J., M.D. | Center for Devices and Radiological Health | Clinical Investigator |
| December 04, 2007 | G.D. Mathews and Sons Corporation dba Mathews Salad House Food Products | New England District Office | Seafood HACCP/Adulterated |
| December 04, 2007 | Wild Edibles, Inc. | New York District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| December 03, 2007 | Pacific Consolidated Industries LLC | Los Angeles District Office | CGMP For Manufacturing, Packing, Storage or Installation/Adulterated |
| November 30, 2007 | Avicenna Laser Technology Inc | Florida District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| November 30, 2007 | Barnacle Seafod, Inc. | Florida District Office | Seafood HAACP/CGMP for Foods/Adulterated |
| November 29, 2007 | E-Med Future, Inc. | Cincinnati District Office | Devices/Quality System Regulation |
| November 28, 2007 | Stryker Orthopaedics Corp. | New Jersey District Office | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| November 28, 2007 | Precision Biometrics, Inc. | Center for Devices and Radiological Health | Device/Lacks Premarket Approval Application/Adulterated/Misbranded |
| November 26, 2007 | Glenn Foods, Inc. | Center for Food Safety and Applied Nutrition | Food Labeling Regulation |
| November 21, 2007 | GlaxoSmithKline | Center for Drug Evaluation and Research | Drug Labeling/Promotional Claims/Misbranded |
| November 21, 2007 | Venosan North America | Center for Devices and Radiological Health | Medical Device Reporting |
| November 19, 2007 | Imperial Trading Company, Inc. | New Orleans District Office | CGMP For Manufacturing, Packing, or Holding Human Food |
| November 19, 2007 | Winchester Bay Fisheries, LLC | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated |
| November 16, 2007 | Custom Assemblies, Inc. | Atlanta District Office | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| November 16, 2007 | Ben Venue Laboratories, Inc. | Cincinnati District Office | CGMP/Deviations/Adulterated |
| November 16, 2007 | GE Healthcare/General Electric Company | Minneapolis District Office | Devices/X-ray Equipment |
| November 14, 2007 | Simco Dairy | Seattle District Office | Animal Sale for Slaughter as Food/Adulterated |
| November 14, 2007 | Visser Ranch | Denver District Office | Animals for Sale for Slaughter as Food/Adulterated |
| November 09, 2007 | Nurse Assist, Inc. | Dallas District Office | CGMP/QSR/Medical Devices/Adulterated |
| November 07, 2007 | Marjon Specialty Food, Inc | Florida District Office | CGMP/Misbranded |
| November 07, 2007 | Amerifit Brands, Inc | New England District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded |
| November 06, 2007 | Ole' Mexican Foods, Inc. | Atlanta District Office | Promotional Claims False & Misleading/Misbranded |
| November 02, 2007 | Fisheries Research Laboratory- SIU-C | Center for Veterinary Medicine | GLP/Bioresearch Monitoring Program |
| November 01, 2007 | Troy Innovative Instruments, Inc. | Cincinnati District Office | CGMP for Medical Devices/QS/Adulterated |
| October 31, 2007 | Northeast General Pharmaceutical Factory | Center for Drug Evaluation and Research | Current Good Manufacturing Practice Regulation/Adulterated |
| October 31, 2007 | Belford Seafood Co-Op | New Jersey District Office | Seafood HACCP/CGMP for Foods/Adulterated |
| October 30, 2007 | International Technidyne Corporation | New Jersey District Office | CGMP/QSR/Medical Device Reporting/Adulterated |
| October 30, 2007 | A La Carte Foods, Inc. | New Orleans District Office | CGMP for Foods/Seafood HACCP/Adulterated |
| October 30, 2007 | VAN Oriental Food, Inc. | Dallas District Office | Seafood HACCP/Adulterated |
| October 30, 2007 | Cytosol Laboratories, Inc. | New England District Office | CGMP/Deviations/Adulterated |
| October 30, 2007 | Chung's Products, LP | Dallas District Office | Seafood HACCP/Adulterated |
| October 29, 2007 | VDS Farms, L.L.C. | Detroit District Office | Animals for Sale for Slaughter as Food/Adulterated |
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