Inspections, Compliance, Enforcement, and Criminal Investigations
2003 Warning Letters
Recently Posted | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |
Tobacco Retailer Warning Letters
Recently Posted | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
Warning Letters issued in 2003
* 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 05, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
December 31, 2003 | Aqua Micron LLC | Denver District Office | CGMP/Finished Pharmaceuticals/Adulterated | N/A * |
December 30, 2003 | Xttrium Laboratories, Inc. | Chicago District Office | Postmarketing Reporting of Adverse Drug Experience | N/A * |
December 30, 2003 | Billy's Sandwiches Inc. | New England District Office | Seafood HACCP/Adulterated | N/A * |
December 30, 2003 | Sunja's Oriental Food Inc. | New England District Office | Seafood HACCP/Adulterated | N/A * |
December 29, 2003 | Mario M. Simoes Dairy #2 | San Francisco District Office | Animals for Sale for Slaughter as Food/Adulterated | N/A * |
December 29, 2003 | TJ Candy Corporation | Dallas District Office | Import/Lacks "May Proceed" or "May Release" | N/A * |
December 29, 2003 | Kos Pharmaceuticals, Inc. | New Jersey District Office | Good Manufacturing Processing, Packing, Holding/Finished Pharmaceuticals/Adulterated | N/A * |
December 29, 2003 | Zirlott's Gulf Products | New Orleans District Office | Seafood HACCP/Adulterated | N/A * |
December 29, 2003 | Lordex Inc | Dallas District Office | Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation | N/A * |
December 29, 2003 | Orleans Poverty Hill Farm | New York District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated | N/A * |
December 23, 2003 | Rusk County Memorial Hospital & Nursing Home | Minneapolis District Office | GMP for Blood & Blood Components/Adulterated | N/A * |
December 23, 2003 | Turner County Dairy, LLP | Minneapolis District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated | N/A * |
December 23, 2003 | H.B. Williams, Inc. | Philadelphia District Office | Illegal Drug Residue/Adulterated | N/A * |
December 23, 2003 | Custom Compounding Centers | Center for Biologics Evaluation and Research | Pharmacy Compounding/GMP for Finished Pharmaceuticals | N/A * |
December 23, 2003 | IND Diagnostic, Inc. | Center for Devices and Radiological Health | CGMP Requirements of the Quality System Regulations/Adulterated | N/A * |
December 23, 2003 | Eldon Biologicals A/S | Center for Devices and Radiological Health | CGMP Requirements of the Quality System Regulations/Adulterated | N/A * |
December 22, 2003 | Staar Surgical Company | Los Angeles District Office | Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation | N/A * |
December 22, 2003 | Prescript Pharmaceuticals, Inc. | San Francisco District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated | N/A * |
December 22, 2003 | Stockpot Incorporated | Seattle District Office | Seafood HACCP/Adulterated | N/A * |
December 19, 2003 | HNK, Inc. | San Francisco District Office | Seafood HACCP/Adulterated | N/A * |
December 19, 2003 | Capital Candy Co., Inc. | New England District Office | Seafood HACCP/Adulterated | N/A * |
December 18, 2003 | Fairfield Farm Kitchens Inc. | New England District Office | Seafood HACCP/Adulterated | N/A * |
December 18, 2003 | Schell's Pine Grove Dairy | Minneapolis District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated | N/A * |
December 18, 2003 | Joe M. Simoes Family Dairy | San Francisco District Office | Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated | N/A * |
December 17, 2003 | Joharra Dairy Farms | Los Angeles District Office | Illegal Drug Residue Animal Tissue/Adulterated | N/A * |
December 17, 2003 | The Net Result | New England District Office | Seafood HACCP/Adulterated | N/A * |
December 17, 2003 | Jesse's Bakery, Inc. | San Francisco District Office | GMP for Food/Food Labeling/Misbranded/Adulterated | N/A * |
December 16, 2003 | Nutralife Laboratories | Los Angeles District Office | New Drug/Nutrition Labeling Dietary Supplements/Misbranded | N/A * |
December 16, 2003 | Russo's Seafood, Inc. | Atlanta District Office | Seafood HACCP/Adulterated | N/A * |
December 16, 2003 | The Food Shop Inc. | New England District Office | Food Labeling/Seafood HACCP/Misbranded/Adulterated | N/A * |
December 15, 2003 | Absolute Packaging Inc | Florida District Office | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated | N/A * |
December 15, 2003 | Central Missouri Agri-Service LLC | Kansas City District Office | Medicated Feeds/Adulterated | N/A * |
December 15, 2003 | Jumbo Foods | Seattle District Office | Seafood HACCP/Adulterated | N/A * |
December 12, 2003 | Floyd Poche Enterprises, Inc. | New Orleans District Office | Food Labeling/Undeclared Ingredients/Misbranded | N/A * |
December 11, 2003 | Ecologic | Center for Food Safety and Applied Nutrition | False & Misleading Claims/New Drug/Misbranded | N/A * |
December 11, 2003 | Caldwell, Stephen H., M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
December 11, 2003 | New York Eye & Ear Infirmary | Center for Devices and Radiological Health | Institutional Review Board | N/A * |
December 11, 2003 | Smith Sterling Dental Laboratory, Inc. | Center for Devices and Radiological Health | Quality System Regulation/Adulterated | N/A * |
December 10, 2003 | Horst's Seafood Co., Inc. | Seattle District Office | Seafood HACCP/Adulterated | N/A * |
December 09, 2003 | James Hook & Co., LLC | New England District Office | Seafood HACCP/Adulterated | N/A * |
December 09, 2003 | Natures Hand | Center for Food Safety and Applied Nutrition | Dietary Supplement/Labeling/False & Misleading Claims/Misbranded | N/A * |
December 09, 2003 | Southside Community Hospital | Baltimore District Office | Blood & Blood Products/Adulterated | N/A * |
December 08, 2003 | Charlie Seafood, Inc. | San Francisco District Office | Seafood HACCP/Adulterated | N/A * |
December 08, 2003 | Western Missouri Medical Center | Kansas City District Office | Blood Bank/GMP for Blood & Blood Components | N/A * |
December 04, 2003 | Odyssey Medical Inc. | New Orleans District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
December 04, 2003 | Philippine Food Distributor | San Francisco District Office | Seafood HACCP/Adulterated | N/A * |
December 04, 2003 | Sun Valley Jerseys | Los Angeles District Office | Illegal Drug Residue Animal Tissue/Extralabel Use/Adulterated | N/A * |
December 04, 2003 | Dairyland Milk Company | Los Angeles District Office | Illegal Drug Residue/Adulterated | N/A * |
December 03, 2003 | Medron, Inc. | Denver District Office | Quality System Reguation/Adulterated | N/A * |
December 03, 2003 | Kral X-Ray, Inc | Atlanta District Office | Performance Standard for Ionizing Radiation Emitting Products | N/A * |
Contact FDA
Division of Freedom of Information (HFI-35)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857