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 |
|---|---|---|---|---|
| November 09, 2001 | St. Anthony Hospital | Seattle District Office | Mammography Quality Standards | N/A * |
| November 09, 2001 | George Weston Bakeries, Inc. | Chicago District Office | Food Labeling/Misbranded | N/A * |
| November 09, 2001 | AstraZeneca AB | Center for Devices and Radiological Health | Deviations from CGMP for Finished Pharmaceuticals | N/A * |
| November 09, 2001 | Accumed, Inc. | New Jersey District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
| November 09, 2001 | Purdue Pharma Inc. | New Jersey District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
| November 09, 2001 | Landshire of Florida, Inc. | Florida District Office | Seafood HACCP | N/A * |
| November 09, 2001 | LifeGas, Ltd. | New Orleans District Office | Current Good Manufacturing Practice Regulations/Oxygen USP/Adulterated | N/A * |
| November 09, 2001 | Purdue Pharma Inc. | New Jersey District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
| November 09, 2001 | ScienceBased Health | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded | N/A * |
| November 09, 2001 | Kaytrad Commodities, Ltd. | Center for Food Safety and Applied Nutrition | Seafood HACCP | N/A * |
| November 09, 2001 | Colt, Inc. | New Orleans District Office | Current Good Manufacturing Practice in manufacturing, packing, or holding human food | N/A * |
| November 09, 2001 | Jackson Clinic North | New Orleans District Office | Mammography Quality Standards | N/A * |
| November 09, 2001 | Mid-Columbia Medical Center | Seattle District Office | Mammography Quality Standards | N/A * |
| November 09, 2001 | Neptune Manufacturing, Inc. | Los Angeles District Office | Seafood HACCP | N/A * |
| November 08, 2001 | Watuga Medical Center | Atlanta District Office | Mammography Quality Standards | N/A * |
| November 08, 2001 | Far Ocean Sea Products Pte., Ltd. | Center for Food Safety and Applied Nutrition | Seafood HACCP | N/A * |
| November 08, 2001 | Kimball Foods, Inc. | Chicago District Office | Seafood HACCP | N/A * |
| November 08, 2001 | Iso-Tex Diagnostics, Inc. | Dallas District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
| November 08, 2001 | Quality Crab Company, Inc. | Atlanta District Office | Seafood HACCP | N/A * |
| November 08, 2001 | Genzyme Corporation | New Jersey District Office | Quality System/Good Manufacturing Practice for Medical Devices/Synvisc Hylan G-F 20/Adulterated | N/A * |
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