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 |
|---|---|---|---|---|
| December 20, 2001 | Port Bolivar Fisheries, Inc. | Dallas District Office | Seafood HACCP | N/A * |
| December 19, 2001 | Conklin Enterprises, Inc. | Atlanta District Office | Seafood HACCP | N/A * |
| December 19, 2001 | Diagnostic Medical Imaging Associates | Cincinnati District Office | Mammography Quality Standards | N/A * |
| December 19, 2001 | Jensen Tuna, Inc. | New Orleans District Office | Seafood HACCP | N/A * |
| December 19, 2001 | King's Oriental Foods Company | Seattle District Office | GMP for Manufacturing, Packing, Holding Food/Seafood HACCP | N/A * |
| December 19, 2001 | The Medical Group | New Orleans District Office | Mammography Quality Standards | N/A * |
| December 19, 2001 | Wayzata Bay Products Inc | Minneapolis District Office | Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated | N/A * |
| December 18, 2001 | Michigan Trading Post | Dallas District Office | Food Labeling/NexCite Dietary Supplement/Misbranded | N/A * |
| December 18, 2001 | Multidata Systems International Corporation | Center for Devices and Radiological Health | Electronic Product Radiation Control/Premarket Notification Requirements/Adulterated/Misbranded | N/A * |
| December 18, 2001 | Atlantic General Hospital | Baltimore District Office | Mammography Quality Standards Act | N/A * |
| December 18, 2001 | Community Radiology Inc. | Cincinnati District Office | Mammography Quality Standards | N/A * |
| December 17, 2001 | Women's Diagnostic Imaging Center | Seattle District Office | Mammography Quality Standards | N/A * |
| December 17, 2001 | King's Fish Market, Inc. | Detroit District Office | Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP | N/A * |
| December 17, 2001 | Camtrade Enterprises, Inc. | San Francisco District Office | Good Manufacturing Practice Requirement for Foods/Seafood HACCP/Adulterated | N/A * |
| December 17, 2001 | Sibley Medical Associates | Baltimore District Office | Mammography Quality Standards | N/A * |
| December 17, 2001 | Carl & Don Frazier, Inc. | Detroit District Office | Seafood HACCP | N/A * |
| December 14, 2001 | Shelly Smith Farm | Atlanta District Office | Illegal Drug Residue/Adulterated | N/A * |
| December 14, 2001 | Van Haitsma Dairy Farm | Detroit District Office | Illegal Drug Tissue Residue/Adulterated | N/A * |
| December 14, 2001 | Natural Technology, Inc. | Dallas District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| December 14, 2001 | Trusted Care | New England District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
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