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 |
---|---|---|---|---|
July 05, 2001 | OBGYN Associates of the Southern Tier | New York District Office | Mammography Quality Standards | N/A * |
July 05, 2001 | Herolds Salads, Inc. | Cincinnati District Office | Seafood HACCP/Good Manufacturing Practice Regulations | N/A * |
July 05, 2001 | Sedecal SA | Center for Devices and Radiological Health | Lacks Submission Product Substantially Equivalent/Misbranded | N/A * |
July 03, 2001 | Frenchy's Seafood Company | Florida District Office | Seafood HACCP | N/A * |
July 02, 2001 | O & L Dairy #2 | Los Angeles District Office | Illegal Drug Tissue Residue/Adulterated | N/A * |
July 02, 2001 | True Worlds Foods, Inc - Rocky Neck Seafoods | New England District Office | Seafood HACCP | N/A * |
July 02, 2001 | Blackburn Brothers, Inc. | Atlanta District Office | Seafood HACCP | N/A * |
July 02, 2001 | Meridian Pharmaceuticals, Inc. | New Orleans District Office | Active Pharmaceutical Ingredients, Repackaging, Relabeling/Adulterated | N/A * |
July 02, 2001 | Katamaran Corporation | Florida District Office | Seafood HACCP | N/A * |
July 02, 2001 | CASA Lab, Inc. | New Orleans District Office | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
July 02, 2001 | Brown Bag Sandwiches, Inc. | Los Angeles District Office | Food Handling & Sanitation Practice/Bacterial Contamination/Adulterated | N/A * |
July 02, 2001 | J-Rob Farms, Inc. | New York District Office | Animal Drug/Adulterated | N/A * |
June 29, 2001 | Del Monte Foods, Inc. | San Francisco District Office | Food Labeling/Adulterated | N/A * |
June 29, 2001 | Aventis Bio-Services | Atlanta District Office | Good Manufacturing Practices for Blood & Blood Components | N/A * |
June 28, 2001 | Ward Sales Company, Inc.` | Atlanta District Office | CGMP/Oxygen Compressed/Adulterated | N/A * |
June 28, 2001 | Yung Shin Pharm. Inc. Col, Ltd. | Center for Drug Evaluation and Research | Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
June 28, 2001 | FIDIA S.P.A. | Center for Drug Evaluation and Research | Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated | N/A * |
June 28, 2001 | Bayshore Community Hospital | Center for Devices and Radiological Health | Institutional Review Board | N/A * |
June 28, 2001 | Vets Plus, Inc. | Minneapolis District Office | GMP for Finished Pharmaceuticals/Unapproved New Animal Drug/Adulterated/Misbranded | N/A * |
June 28, 2001 | DMS Imaging, Inc. | Minneapolis District Office | Mammography Quality Standards | N/A * |
June 28, 2001 | Atlantic Steamers Supply Company | Dallas District Office | Interstate Conveyance Sanitation/Insanitary Conditions | N/A * |
June 28, 2001 | Sushi Sushi, Inc. | New England District Office | Seafood HACCP | N/A * |
June 28, 2001 | Carl's Seafood | New Orleans District Office | Seafood HACCP/Vacuum Packed Crawfish Tail Meat | N/A * |
June 27, 2001 | Atchison Hospital | Dallas District Office | Mammography Quality Standards | N/A * |
June 27, 2001 | Prizm Medical Inc. | Atlanta District Office | Quality System Regulation/Electrotherapy Products/Adulterated | N/A * |
June 27, 2001 | Perkins County Health Services | Dallas District Office | Mammography Quality Standards | N/A * |
June 27, 2001 | Bayou Land Seafood, LLC | New Orleans District Office | Seafood HACCP/Vacuum Packed Crawfish Tail Meat/Adulterated | N/A * |
June 26, 2001 | Community Hospital - South | Detroit District Office | Mammography Quality Standards | N/A * |
June 26, 2001 | Nassau Health Care Corporation Mammography Center | New York District Office | Mammography Quality Standards | N/A * |
June 26, 2001 | Kell West Regional Hospital | Dallas District Office | Mammography Quality Standards | N/A * |
June 26, 2001 | Alta Bates Medical Center | San Francisco District Office | Mammography Quality Standards | N/A * |
June 26, 2001 | Howard Community Hospital | Detroit District Office | Mammography Quality Standards | N/A * |
June 25, 2001 | Sea Food World | San Francisco District Office | Seafood HACCP/GMP for Foods/Fresh Tuna & Marlin/Adulterated | N/A * |
June 25, 2001 | A.T. Radiology | Florida District Office | Mammography Quality Standards | N/A * |
June 25, 2001 | Kinston Radiological Associates | Atlanta District Office | Mammography Quality Standards | N/A * |
June 25, 2001 | Fresh Island Seafood Hub | San Francisco District Office | Seafood HACCP/Good Manufacturing Practices Requirement for Foods | N/A * |
June 25, 2001 | Holy Cross Medical Group | Florida District Office | Mammography Quality Standards | N/A * |
June 25, 2001 | EAS Inc. | Center for Food Safety and Applied Nutrition | Food Labeling/Misbranded | N/A * |
June 25, 2001 | Transplantation Research Foundation | Dallas District Office | QSR/Lacks Premarket Application/Human Dura Mater Allografts/Adulterated/Misbranded | N/A * |
June 25, 2001 | Nu-Day Snacks Inc. | Center for Food Safety and Applied Nutrition | Food Labeling/Misbranded | N/A * |
June 25, 2001 | Sampson Regional Medical Center | Atlanta District Office | Mammography Quality Standards | N/A * |
June 25, 2001 | Countyline Dairy | Denver District Office | Illegal Drug Tissue Residue | N/A * |
June 22, 2001 | Oakland View Farms | Baltimore District Office | Illegal Drug Tissue Residue/Adulterated | N/A * |
June 22, 2001 | Rockhill Dairy LLC | Denver District Office | Illegal Drug Tissue Residue | N/A * |
June 22, 2001 | Pinehurst Women's Clinic, P.A. | Atlanta District Office | Mammography Quality Standards | N/A * |
June 22, 2001 | Louis C. Mathews Seafood | Atlanta District Office | Seafood HACCP | N/A * |
June 22, 2001 | Cape Medical Supply, Inc. | New England District Office | CGMP for Finished Pharmceuticals/Oxygen Filling Facility/Adulterated | N/A * |
June 22, 2001 | Christus Coushatta Health Care Center | New Orleans District Office | Mammography Quality Standards | N/A * |
June 21, 2001 | Pacific Seafood Group - Washington Crab Producers, Inc. | Seattle District Office | Shrimp/Adulterated | N/A * |
June 21, 2001 | Pacific Seafood Group - Inland Quick Freeze | Seattle District Office | Shrimp/Adulterated | N/A * |
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