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Inspections, Compliance, Enforcement, and Criminal Investigations
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2003 Warning Letters
Warning Letters for 2003
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| December 31, 2003 | Aqua Micron LLC | Denver District Office | CGMP/Finished Pharmaceuticals/Adulterated |
| December 30, 2003 | Sunja's Oriental Food Inc. | New England District Office | Seafood HACCP/Adulterated |
| December 30, 2003 | Billy's Sandwiches Inc. | New England District Office | Seafood HACCP/Adulterated |
| December 30, 2003 | Xttrium Laboratories, Inc. | Chicago District Office | Postmarketing Reporting of Adverse Drug Experience |
| December 29, 2003 | Mario M. Simoes Dairy #2 | San Francisco District Office | Animals for Sale for Slaughter as Food/Adulterated |
| December 29, 2003 | Orleans Poverty Hill Farm | New York District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated |
| December 29, 2003 | TJ Candy Corporation | Dallas District Office | Import/Lacks "May Proceed" or "May Release" |
| December 29, 2003 | Zirlott's Gulf Products | New Orleans District Office | Seafood HACCP/Adulterated |
| December 29, 2003 | Lordex Inc | Dallas District Office | Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation |
| December 29, 2003 | Kos Pharmaceuticals, Inc. | New Jersey District Office | Good Manufacturing Processing, Packing, Holding/Finished Pharmaceuticals/Adulterated |
| December 23, 2003 | Custom Compounding Centers | Center for Biologics Evaluation and Research | Pharmacy Compounding/GMP for Finished Pharmaceuticals |
| December 23, 2003 | Rusk County Memorial Hospital & Nursing Home | Minneapolis District Office | GMP for Blood & Blood Components/Adulterated |
| December 23, 2003 | Eldon Biologicals A/S | Center for Devices and Radiological Health | CGMP Requirements of the Quality System Regulations/Adulterated |
| December 23, 2003 | IND Diagnostic, Inc. | Center for Devices and Radiological Health | CGMP Requirements of the Quality System Regulations/Adulterated |
| December 23, 2003 | Turner County Dairy, LLP | Minneapolis District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated |
| December 23, 2003 | H.B. Williams, Inc. | Philadelphia District Office | Illegal Drug Residue/Adulterated |
| December 22, 2003 | Prescript Pharmaceuticals, Inc. | San Francisco District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated |
| December 22, 2003 | Stockpot Incorporated | Seattle District Office | Seafood HACCP/Adulterated |
| December 22, 2003 | Staar Surgical Company | Los Angeles District Office | Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation |
| December 19, 2003 | HNK, Inc. | San Francisco District Office | Seafood HACCP/Adulterated |
| December 19, 2003 | Capital Candy Co., Inc. | New England District Office | Seafood HACCP/Adulterated |
| December 18, 2003 | Joe M. Simoes Family Dairy | San Francisco District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated |
| December 18, 2003 | Schell's Pine Grove Dairy | Minneapolis District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated |
| December 18, 2003 | Fairfield Farm Kitchens Inc. | New England District Office | Seafood HACCP/Adulterated |
| December 17, 2003 | The Net Result | New England District Office | Seafood HACCP/Adulterated |
| December 17, 2003 | Jesse's Bakery, Inc. | San Francisco District Office | GMP for Food/Food Labeling/Misbranded/Adulterated |
| December 17, 2003 | Joharra Dairy Farms | Los Angeles District Office | Illegal Drug Residue Animal Tissue/Adulterated |
| December 16, 2003 | Nutralife Laboratories | Los Angeles District Office | New Drug/Nutrition Labeling Dietary Supplements/Misbranded |
| December 16, 2003 | Russo's Seafood, Inc. | Atlanta District Office | Seafood HACCP/Adulterated |
| December 16, 2003 | The Food Shop Inc. | New England District Office | Food Labeling/Seafood HACCP/Misbranded/Adulterated |
| December 15, 2003 | Central Missouri Agri-Service LLC | Kansas City District Office | Medicated Feeds/Adulterated |
| December 15, 2003 | Absolute Packaging Inc | Florida District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated |
| December 15, 2003 | Jumbo Foods | Seattle District Office | Seafood HACCP/Adulterated |
| December 12, 2003 | Floyd Poche Enterprises, Inc. | New Orleans District Office | Food Labeling/Undeclared Ingredients/Misbranded |
| December 11, 2003 | Ecologic | Center for Food Safety and Applied Nutrition | False & Misleading Claims/New Drug/Misbranded |
| December 11, 2003 | New York Eye & Ear Infirmary | Center for Devices and Radiological Health | Institutional Review Board |
| December 11, 2003 | Caldwell, Stephen H., M.D. | Center for Devices and Radiological Health | Clinical Investigator |
| December 11, 2003 | Smith Sterling Dental Laboratory, Inc. | Center for Devices and Radiological Health | Quality System Regulation/Adulterated |
| December 10, 2003 | Horst's Seafood Co., Inc. | Seattle District Office | Seafood HACCP/Adulterated |
| December 09, 2003 | James Hook & Co., LLC | New England District Office | Seafood HACCP/Adulterated |
| December 09, 2003 | Natures Hand | Center for Food Safety and Applied Nutrition | Dietary Supplement/Labeling/False & Misleading Claims/Misbranded |
| December 09, 2003 | Southside Community Hospital | Baltimore District Office | Blood & Blood Products/Adulterated |
| December 08, 2003 | Western Missouri Medical Center | Kansas City District Office | Blood Bank/GMP for Blood & Blood Components |
| December 08, 2003 | Charlie Seafood, Inc. | San Francisco District Office | Seafood HACCP/Adulterated |
| December 04, 2003 | Odyssey Medical Inc. | New Orleans District Office | Quality System Regulation for Medical Devices/Adulterated |
| December 04, 2003 | Sun Valley Jerseys | Los Angeles District Office | Illegal Drug Residue Animal Tissue/Extralabel Use/Adulterated |
| December 04, 2003 | Dairyland Milk Company | Los Angeles District Office | Illegal Drug Residue/Adulterated |
| December 04, 2003 | Philippine Food Distributor | San Francisco District Office | Seafood HACCP/Adulterated |
| December 03, 2003 | Kral X-Ray, Inc | Atlanta District Office | Performance Standard for Ionizing Radiation Emitting Products |
| December 03, 2003 | Medron, Inc. | Denver District Office | Quality System Reguation/Adulterated |
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