Inspections, Compliance, Enforcement, and Criminal Investigations
2001 Warning Letters
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Warning Letters for 2001
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* 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 July 23, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
June 21, 2001 | Taku Smokeries/Fisheries | Seattle District Office | Seafood HACCP/Smoked Salmon | N/A * |
June 21, 2001 | F.E. Warren AFB | Dallas District Office | Mammography Quality Standards | N/A * |
June 20, 2001 | Angel Medical Center | Atlanta District Office | Mammography Quality Standards | N/A * |
June 20, 2001 | Marshall Medical Center North | New Orleans District Office | Mammography Quality Standards | N/A * |
June 20, 2001 | Hugh Chatman Memorial Hospital | Atlanta District Office | Mammography Quality Standards | N/A * |
June 20, 2001 | Chung Farming | Florida District Office | Insanitary Conditions/Sprout Production Facility/Adulterated | N/A * |
June 20, 2001 | Washington County Memorial Hospital | Dallas District Office | Mammography Quality Standards | N/A * |
June 20, 2001 | Newman Foods Inc | Seattle District Office | Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions | N/A * |
June 20, 2001 | Dallas Southwest Medical Center | Dallas District Office | Mammography Quality Standards | N/A * |
June 20, 2001 | Bui Family Seafood Company | New Orleans District Office | Seafood HACCP/Cooked Crabmeat | N/A * |
June 20, 2001 | Morico Foods Inc. | Center for Food Safety and Applied Nutrition | Food Labeling/Carbolite/Misbranded | N/A * |
June 20, 2001 | Rich Nature Nutraceutical Laboratories Inc | Seattle District Office | New Drug/Labeling/Misbranded | N/A * |
June 20, 2001 | Kofkoff Egg Farms LLC | New England District Office | Current Good Manufacturing Practice for Medicated Feeds/Adulterated | N/A * |
June 19, 2001 | X-Cel X-Ray Corporation | Chicago District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
June 19, 2001 | Nutraceutical International Corporation | Denver District Office | Red Yeast Rice Product/Lacks Approved New Drug Application/Misbranded | N/A * |
June 19, 2001 | Nature's Sunshine Products, Inc. | Denver District Office | Lovastatin/Red Yeast Rice Product/Lacks Approved New Drug Application | N/A * |
June 19, 2001 | Variety Food Services Inc. | Detroit District Office | Nutrition Labeling of Food/Misbranded | N/A * |
June 19, 2001 | Symedex Medical Aesthetic Solutions | Center for Devices and Radiological Health | MD 2000 & MD2 therapeutic Massagers/Lacks Premarket Approval/Adulterated/Misbranded | N/A * |
June 19, 2001 | Silveira Dairy | San Francisco District Office | Animal Drug/Adulterated | N/A * |
June 19, 2001 | Sanofi-Synthelabo Incorporated | Center for Devices and Radiological Health | Hyalgan/Lacks Premarket Approval/Adulterated/Misbranded | N/A * |
June 18, 2001 | Salsbury Chemicals Inc. | Kansas City District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
June 18, 2001 | Quaker Oats Company | Dallas District Office | Food Labeling/Misbranded | N/A * |
June 18, 2001 | So-Good Inc | Chicago District Office | Good Manufacturing Practice Regulations for Foods/Seafood HACCP | N/A * |
June 18, 2001 | Lake Cumberland Medical Associates | Cincinnati District Office | Mammography Quality Standards | N/A * |
June 18, 2001 | Regional Radiology LLC | New Jersey District Office | Mammography Quality Standards | N/A * |
June 15, 2001 | North Point Dairy | Denver District Office | Illegal Drug Tissue Residue | N/A * |
June 15, 2001 | Electric Beach | Cincinnati District Office | Performance Standard for Sunlamp Products | N/A * |
June 15, 2001 | 67th Combat Support Hospital | Dallas District Office | Mammography Quality Standards | N/A * |
June 15, 2001 | St. Mary Hospital | New Jersey District Office | Mammography Quality Standards | N/A * |
June 15, 2001 | Central Diagnostic Imaging Network | Los Angeles District Office | Mammography Quality Standards | N/A * |
June 15, 2001 | Little River Fish House Inc | Atlanta District Office | Seafood HACCP | N/A * |
June 15, 2001 | Edge Biologicals Inc | New Orleans District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
June 14, 2001 | J. Kenneth Fussell | New Orleans District Office | Animal Drug/Adulterated | N/A * |
June 14, 2001 | A N T Imaging Center | Los Angeles District Office | Mammography Quality Standards | N/A * |
June 14, 2001 | LAC/Olive View Medical Center | Los Angeles District Office | Mammography Quality Standards | N/A * |
June 14, 2001 | J. Kenneth Fussell | New Orleans District Office | Animal Drug/Adulterated | N/A * |
June 14, 2001 | Marianna Inc. | Kansas City District Office | CGMP for Finished Pharmaceutical/Adulterated | N/A * |
June 14, 2001 | High Desert Dairy | Los Angeles District Office | Animal Drug/Adulterated | N/A * |
June 14, 2001 | Westchester Imaging Medical Group | Los Angeles District Office | Mammography Quality Standards | N/A * |
June 13, 2001 | Johns Hopkins Breast Imaging | Baltimore District Office | Mammography Quality Standards | N/A * |
June 13, 2001 | Rich Products Corporation | Buffalo District Office | Baked Goods/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
June 13, 2001 | HR Beal & Sons | New England District Office | Seafood HACCP/Vacuum-Packed Cooked Lobster Meat | N/A * |
June 12, 2001 | Moran Rowen & Dorsey Inc. - Breast Imaging Center | Los Angeles District Office | Mammography Quality Standards | N/A * |
June 12, 2001 | Integral Fish Foods Inc. | Denver District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
June 11, 2001 | Meridian Bioscience Inc. | Cincinnati District Office | In-Vitro Diagnostic Products/Quality System Regulation/Adulterated | N/A * |
June 11, 2001 | Great Plains Food Company | Denver District Office | Seafood HACCP/Alligator Products | N/A * |
June 11, 2001 | Telstar Innovations Inc. | Center for Devices and Radiological Health | Lacks Approved Premarket Application/Adulterated/Misbranded | N/A * |
June 11, 2001 | TheraTest Laboratories Inc | Chicago District Office | In Vitro Diagnostic Kits/Quality System Regulation for Medical Devices/Adulterated | N/A * |
June 11, 2001 | Walmart Stores | Florida District Office | Shipment/Lacks"May Proceed Notice" or "Release Notice" | N/A * |
June 08, 2001 | Smucker Quality Beverages Inc. | Center for Food Safety and Applied Nutrition | Food Labeling/Lacks Approved New Drug Application/Misbranded | N/A * |
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