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Inspections, Compliance, Enforcement, and Criminal Investigations
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2004 Warning Letters
Warning Letters for 2004
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| December 30, 2004 | Bozenkill Dairy Farm | New York District Office | Animals for Sale for Slaughter as Food/Adulterated |
| December 29, 2004 | Medefil, Inc. | Chicago District Office | Quality System Regulation for Medical Devices/Adulterated |
| December 28, 2004 | West Bay Seafood Co., Inc. | San Francisco District Office | Seafood HACCP/Adulterated |
| December 27, 2004 | BioHorizons Implant Systems, Inc. | New Orleans District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated |
| December 23, 2004 | Wingate Seafood, LLC | Baltimore District Office | Seafood HACCP/Adulterated |
| December 23, 2004 | Best Veterinary Solutions, Inc. | Minneapolis District Office | Labeling/Adulterated |
| December 22, 2004 | Cyberonics, Inc. | Dallas District Office | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated |
| December 22, 2004 | Advanced Sterilization Products | Los Angeles District Office | Good Manufacturing Practice Requirement for the Quality System Regulation/Adulterated |
| December 22, 2004 | Huebner Farm | Minneapolis District Office | Extralabel Drug Use in Animals/Adulterated |
| December 21, 2004 | Borawski, Lawrence A. | Florida District Office | Labeling/False & Misleading Claims/Misbranded |
| December 21, 2004 | Just Fabulous Pastries, Inc. | Los Angeles District Office | Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions |
| December 21, 2004 | Denver Tofu Company, Inc. | Denver District Office | Labeling/Promotional Claims False & Misleading/Misbranded |
| December 21, 2004 | N64 Neutraceutica | Detroit District Office | Labeling/False & Misleading Claims/Misbranded |
| December 21, 2004 | Nelson Laboratories, Inc. | Center for Devices and Radiological Health | Good Laboratory Practices |
| December 21, 2004 | Euro-USA Trading Co., Inc. | New England District Office | Food Labeling/Misbranded |
| December 20, 2004 | Respi Care Group of Puerto Rico | San Juan District Office | Unapproved New Drug/Adulterated/Misbranded |
| December 20, 2004 | Jessie's Ilwaco Fish Co, Inc. | Seattle District Office | Seafood HACCP/Adulterated |
| December 17, 2004 | Galens Garden | Center for Food Safety and Applied Nutrition | Labeling/New Drug/False & Misleading Claims/Misbranded |
| December 17, 2004 | Red River Pharmacy Services, Inc. | Dallas District Office | Active Pharmaceutical Ingredient/Adulterated |
| December 17, 2004 | U R Farms | Seattle District Office | Extralabel Drug Use in Animals/Adulterated |
| December 17, 2004 | The Meat Market, Inc. | San Francisco District Office | Seafood HACCP/Adulterated |
| December 15, 2004 | Prime Veal Feed, Ltd. | Cincinnati District Office | Extralabel Drug Use in Animals/Misbranded |
| December 15, 2004 | Precision Piece Parts, Inc. | Detroit District Office | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated |
| December 15, 2004 | Roxy Trading, Inc. | Los Angeles District Office | Seafood HACCP/Adulterated |
| December 15, 2004 | White Egret Farm | Dallas District Office | Control of Communicable Disease |
| December 15, 2004 | Parker Foods, LLC | Los Angeles District Office | Seafood HACCP/Adulterated |
| December 15, 2004 | Kling, Mitchel A., M.D. | Center for Devices and Radiological Health | Clinical Investigator |
| December 15, 2004 | Nolan Livestock | Minneapolis District Office | Extralabel Drug Use in Animals/Adulterated |
| December 14, 2004 | TODDS | Los Angeles District Office | Seafood HACCP/Adulterated |
| December 14, 2004 | Kinton, Inc. | New Jersey District Office | Seafood HACCP/Adulterated |
| December 14, 2004 | Nature's Way Products, Inc. | Denver District Office | Food/Adulterated |
| December 14, 2004 | Gourmet Kitchen, Inc. | New Jersey District Office | CGMP for Foods/Seafood HACCP/Adulterated |
| December 14, 2004 | Can-x Products | Minneapolis District Office | Lacks New Drug Approval /Misbranded |
| December 10, 2004 | Jean's Greens | New York District Office | Labeling/Promotional Claims False & Misleading/Misbranded |
| December 10, 2004 | The Sanapac Co., Inc. | Philadelphia District Office | Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded |
| December 10, 2004 | Collins, Tyrone J., M.D. | Center for Devices and Radiological Health | Clinical Investigator |
| December 09, 2004 | Lincare, Inc. | New Orleans District Office | Pharmacy Compounding/Misbranded |
| December 09, 2004 | Chiron Corporation | Office of Enforcement | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated |
| December 09, 2004 | Danlee Medical Products, Inc. | New York District Office | Quality System Regulation for Medical Devices/Adulterated/Misbranded |
| December 09, 2004 | Sunshine Mills, Inc. | New Orleans District Office | Animal Proteins Prohibited in Ruminant Feed/Misbranded |
| December 08, 2004 | Continental Caviar | New Orleans District Office | Seafood HACCP/Adulterated/Misbranded |
| December 08, 2004 | Lamar Seafood Corporation | Florida District Office | Seafood HACCP/Adulterated |
| December 08, 2004 | Veterinary Enterprises of Tomorrow, Inc. | Dallas District Office | Active Pharmaceutical Ingredient/Adulterated |
| December 07, 2004 | Lex, Inc. | Florida District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded |
| December 07, 2004 | Goya Foods, Inc. | New Jersey District Office | Labeling/False & Misleading Claims/Adulterated/Misbranded |
| December 06, 2004 | Weyand Fisheries, Inc. | Detroit District Office | Seafood HACCP/Adulterated |
| December 06, 2004 | California Natural Products | San Francisco District Office | Low-Acid Foods/Adulterated |
| December 03, 2004 | Mind's Eye Juice Company | Seattle District Office | CGMP for Foods/Juice HACCP/Adulterated/Misbranded |
| December 02, 2004 | Purest Colloids, Inc. | New Jersey District Office | Promotional Claims/False & Misleading/Misbranded |
| December 02, 2004 | Colloids for Life, LLC | Denver District Office | Labeling/Promotional Claims False & Misleading/New Drug |
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