Inspections, Compliance, Enforcement, and Criminal Investigations
2001 Warning Letters
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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 13, 2001 | New Japan International Inc. | Los Angeles District Office | Salmonella Contamination/Adulterated | N/A * |
November 13, 2001 | OB/GYN Group/Imaging | Dallas District Office | Mammography Quality Standards | N/A * |
November 13, 2001 | Holy Cross Hospital | Dallas District Office | Mammography Quality Standards | N/A * |
November 13, 2001 | Medical Imaging Center | Dallas District Office | Mammography Quality Standards | N/A * |
November 13, 2001 | Sally Jobe Breast Diagnostic & Counseling Center | Dallas District Office | Mammography Quality Standards | N/A * |
November 09, 2001 | Accumed, Inc. | New Jersey District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
November 09, 2001 | F.A.V. International Corp. | Florida District Office | Stoneware Mugs/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
November 09, 2001 | Sea Market Inc. | Florida District Office | Seafood HACCP | N/A * |
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 | 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 | Finlayson Ag Center | Minneapolis District Office | Animal Proteins Prohibited in Ruminant Feed/Adulterated | N/A * |
November 08, 2001 | Greenwood Imaging Center, P.A. | Atlanta District Office | Mammography Quality Standards | N/A * |
November 08, 2001 | Charles A. Cannon, Jr. Memorial Hospital | Atlanta District Office | Mammography Quality Standards | 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 * |
November 07, 2001 | Community Radiology, P.A. | New Jersey District Office | Mammography Quality Standards | N/A * |
November 07, 2001 | Aventura Diagnostic Center | Florida District Office | Mammography Quality Standards | N/A * |
November 07, 2001 | Fair Oaks Hospital Medical Plaza | Baltimore District Office | Mammography Quality Standards | N/A * |
November 07, 2001 | Sea-Lect Wholesale Seafood Inc. | New Jersey District Office | Seafood HACCP | N/A * |
November 06, 2001 | Eye Centers of Florida | Florida District Office | Human Tissue Intended for Transportation | N/A * |
November 05, 2001 | Miller II, Damon P., M.D. | Center for Devices and Radiological Health | Labeling/Lacks Premarket Notification | N/A * |
November 05, 2001 | Art's Trading Company | San Francisco District Office | Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated | N/A * |
November 05, 2001 | ARJO, Ltd. | Center for Devices and Radiological Health | Quality System Regulation/Adulterated | N/A * |
November 05, 2001 | Westchester-Bronx OB/Gyn Group, P.C. | Buffalo District Office | Mammography Quality Standards | N/A * |
November 05, 2001 | Saint Dominic's Hospital | San Francisco District Office | Mammography Quality Standards | N/A * |
November 05, 2001 | Borgess- Pipp Health Center | Detroit District Office | Mammography Quality Standards | N/A * |
November 05, 2001 | Diomed Inc. | Center for Devices and Radiological Health | Lacks Premarket Notification/Misbranded/Adulterated | N/A * |
November 02, 2001 | Baxter Healthcare Corporation | Chicago District Office | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals | N/A * |
November 01, 2001 | Gorman, John F., M.D. | Buffalo District Office | Mammography Quality Standards | N/A * |
October 31, 2001 | Stewarts Seafood Inc. | New Orleans District Office | Seafood HACCP | N/A * |
October 31, 2001 | Four Star Dairy | Cincinnati District Office | Illegal Drug Residue/Adulterated | N/A * |
October 31, 2001 | Fairfield Medical Center | Cincinnati District Office | Mammography Quality Standards | N/A * |
October 31, 2001 | Fairfield Medical Center Diagnostic Health Services | Cincinnati District Office | Mammography Quality Standards Act | N/A * |
October 30, 2001 | Emergent Innovations, LLC. | Detroit District Office | Quality System Regulations/Medical Device Reporting/Adulterated/Misbranded | N/A * |
October 30, 2001 | Avax Technologies, Inc. | Center for Biologics Evaluation and Research | Sponsor/Monitor/Contract Research Organization | N/A * |
October 29, 2001 | Trans Caribbean Dairy Corporation | San Juan District Office | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food/Adulterated | N/A * |
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