Inspections, Compliance, Enforcement, and Criminal Investigations
2004 Warning Letters
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Warning Letters issued in 2004
* 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 May 04, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 30, 2004 | Bozenkill Dairy Farm | New York District Office | Animals for Sale for Slaughter as Food/Adulterated | N/A * |
December 29, 2004 | Medefil, Inc. | Chicago District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
December 28, 2004 | West Bay Seafood Co., Inc. | San Francisco District Office | Seafood HACCP/Adulterated | N/A * |
December 27, 2004 | BioHorizons Implant Systems, Inc. | New Orleans District Office | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated | N/A * |
December 23, 2004 | Wingate Seafood, LLC | Baltimore District Office | Seafood HACCP/Adulterated | N/A * |
December 23, 2004 | Best Veterinary Solutions, Inc. | Minneapolis District Office | Labeling/Adulterated | N/A * |
December 22, 2004 | Huebner Farm | Minneapolis District Office | Extralabel Drug Use in Animals/Adulterated | N/A * |
December 22, 2004 | Advanced Sterilization Products | Los Angeles District Office | Good Manufacturing Practice Requirement for the Quality System Regulation/Adulterated | N/A * |
December 22, 2004 | Cyberonics, Inc. | Dallas District Office | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
December 21, 2004 | Just Fabulous Pastries, Inc. | Los Angeles District Office | Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions | N/A * |
December 21, 2004 | Denver Tofu Company, Inc. | Denver District Office | Labeling/Promotional Claims False & Misleading/Misbranded | N/A * |
December 21, 2004 | Nelson Laboratories, Inc. | Center for Devices and Radiological Health | Good Laboratory Practices | N/A * |
December 21, 2004 | Euro-USA Trading Co., Inc. | New England District Office | Food Labeling/Misbranded | N/A * |
December 21, 2004 | N64 Neutraceutica | Detroit District Office | Labeling/False & Misleading Claims/Misbranded | N/A * |
December 21, 2004 | Borawski, Lawrence A. | Florida District Office | Labeling/False & Misleading Claims/Misbranded | N/A * |
December 20, 2004 | Jessie's Ilwaco Fish Co, Inc. | Seattle District Office | Seafood HACCP/Adulterated | N/A * |
December 20, 2004 | Respi Care Group of Puerto Rico | San Juan District Office | Unapproved New Drug/Adulterated/Misbranded | N/A * |
December 17, 2004 | U R Farms | Seattle District Office | Extralabel Drug Use in Animals/Adulterated | N/A * |
December 17, 2004 | The Meat Market, Inc. | San Francisco District Office | Seafood HACCP/Adulterated | N/A * |
December 17, 2004 | Red River Pharmacy Services, Inc. | Dallas District Office | Active Pharmaceutical Ingredient/Adulterated | N/A * |
December 17, 2004 | Galens Garden | Center for Food Safety and Applied Nutrition | Labeling/New Drug/False & Misleading Claims/Misbranded | N/A * |
December 15, 2004 | Parker Foods, LLC | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
December 15, 2004 | Precision Piece Parts, Inc. | Detroit District Office | CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated | N/A * |
December 15, 2004 | Roxy Trading, Inc. | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
December 15, 2004 | Prime Veal Feed, Ltd. | Cincinnati District Office | Extralabel Drug Use in Animals/Misbranded | N/A * |
December 15, 2004 | Kling, Mitchel A., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 15, 2004 | White Egret Farm | Dallas District Office | Control of Communicable Disease | N/A * |
December 15, 2004 | Nolan Livestock | Minneapolis District Office | Extralabel Drug Use in Animals/Adulterated | N/A * |
December 14, 2004 | TODDS | Los Angeles District Office | Seafood HACCP/Adulterated | N/A * |
December 14, 2004 | Kinton, Inc. | New Jersey District Office | Seafood HACCP/Adulterated | N/A * |
December 14, 2004 | Nature's Way Products, Inc. | Denver District Office | Food/Adulterated | N/A * |
December 14, 2004 | Gourmet Kitchen, Inc. | New Jersey District Office | CGMP for Foods/Seafood HACCP/Adulterated | N/A * |
December 14, 2004 | Can-x Products | Minneapolis District Office | Lacks New Drug Approval /Misbranded | N/A * |
December 10, 2004 | Jean's Greens | New York District Office | Labeling/Promotional Claims False & Misleading/Misbranded | N/A * |
December 10, 2004 | The Sanapac Co., Inc. | Philadelphia District Office | Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded | N/A * |
December 10, 2004 | Collins, Tyrone J., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 09, 2004 | Lincare, Inc. | New Orleans District Office | Pharmacy Compounding/Misbranded | N/A * |
December 09, 2004 | Sunshine Mills, Inc. | New Orleans District Office | Animal Proteins Prohibited in Ruminant Feed/Misbranded | N/A * |
December 09, 2004 | Chiron Corporation | Office of Enforcement | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated | N/A * |
December 09, 2004 | Danlee Medical Products, Inc. | New York District Office | Quality System Regulation for Medical Devices/Adulterated/Misbranded | N/A * |
December 08, 2004 | Veterinary Enterprises of Tomorrow, Inc. | Dallas District Office | Active Pharmaceutical Ingredient/Adulterated | N/A * |
December 08, 2004 | Lamar Seafood Corporation | Florida District Office | Seafood HACCP/Adulterated | N/A * |
December 08, 2004 | Continental Caviar | New Orleans District Office | Seafood HACCP/Adulterated/Misbranded | N/A * |
December 07, 2004 | Lex, Inc. | Florida District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded | N/A * |
December 07, 2004 | Goya Foods, Inc. | New Jersey District Office | Labeling/False & Misleading Claims/Adulterated/Misbranded | N/A * |
December 06, 2004 | Weyand Fisheries, Inc. | Detroit District Office | Seafood HACCP/Adulterated | N/A * |
December 06, 2004 | California Natural Products | San Francisco District Office | Low-Acid Foods/Adulterated | N/A * |
December 03, 2004 | Mind's Eye Juice Company | Seattle District Office | CGMP for Foods/Juice HACCP/Adulterated/Misbranded | N/A * |
December 02, 2004 | Colloids for Life, LLC | Denver District Office | Labeling/Promotional Claims False & Misleading/New Drug | N/A * |
December 02, 2004 | Purest Colloids, Inc. | New Jersey District Office | Promotional Claims/False & Misleading/Misbranded | N/A * |
Contact FDA
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Food and Drug Administration
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