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 |
|---|---|---|---|---|
| September 28, 2001 | Milan General Hospital | New Orleans District Office | Mammography Quality Standards | N/A * |
| September 27, 2001 | Duck Delivery Produce, Inc. | Seattle District Office | Seafood HACCP/Adulterated | N/A * |
| September 27, 2001 | Interstate Brands Corporation | Chicago District Office | Food Labeling/Misbranded | N/A * |
| September 27, 2001 | Mrs. Seibold's Bakery, Inc. | Chicago District Office | Insanitary Conditions/Adulterated | N/A * |
| September 27, 2001 | American Blending and Filling | Chicago District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| September 27, 2001 | Unilever HPC-USA | Chicago District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| September 27, 2001 | Focal Pointe Women | Atlanta District Office | Mammography Quality Standards | N/A * |
| September 27, 2001 | Gloucester Seafood Display Auction | New England District Office | Seafood HACCP/Bluefish | N/A * |
| September 27, 2001 | Duck Delivery Produce, Inc. | Seattle District Office | Seafood HACCP/Adulterated | N/A * |
| September 27, 2001 | Christ Hospital | Chicago District Office | Current Good Manufacturing Practices for Blood and Blood Components | N/A * |
| September 27, 2001 | International Science & Technology, L.P. | Dallas District Office | CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded | N/A * |
| September 26, 2001 | Cameron-Miller, Inc. | Chicago District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
| September 26, 2001 | Dentsply International, Inc. | Chicago District Office | Quality System Regulation for Medical Devices/Adulterated | N/A * |
| September 26, 2001 | Kabco, Inc. | New York District Office | Cholestrol Support Capsules/Unapproved New Drug Application/Misbranded | N/A * |
| September 26, 2001 | Black River Produce Earth Brothers Ltd. | New England District Office | Seafood HACCP | N/A * |
| September 25, 2001 | Hako-Med Electromedicine, Incorporated | Center for Devices and Radiological Health | Device/Lacks Approved Premarket Application/Adulterated/Misbranded | N/A * |
| September 25, 2001 | Schuster Services & Blue Mountain Water | San Juan District Office | Food Labeling/Processing & Standard Identity for Bottled Drinking Water/Adulterated/Misbranded | N/A * |
| September 24, 2001 | Wityk, Goad, Korangy and Associates | Baltimore District Office | Mammography Quality Standards | N/A * |
| September 24, 2001 | Hull Street Diagnostic Center | Baltimore District Office | Mammography Quality Standards | N/A * |
| September 24, 2001 | Robin Drug Corporation | Minneapolis District Office | CGMP for Finished Pharmaceuticals/Drugs Repacking Facility/Adulterated | N/A * |
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