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 May 26, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
March 28, 2001 | Uwajimaya Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
March 28, 2001 | Hardin Memorial Hospital | Cincinnati District Office | Mammography Standards | N/A * |
March 28, 2001 | Gangi Seafood Inc. | New Orleans District Office | Seafood Processing Regulations/HACCP | N/A * |
March 28, 2001 | St. Elizabeth Health Center | Cincinnati District Office | Mammography Standards | N/A * |
March 27, 2001 | Tri County Hospital | Minneapolis District Office | Mammography Standards | N/A * |
March 27, 2001 | Z & W Mill Inc. | Denver District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
March 27, 2001 | Northern Fish Products Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
March 27, 2001 | Yahal USA | Center for Devices and Radiological Health | Performance Standard for Electronic/Laser Products | N/A * |
March 27, 2001 | Happy Tofu Inc. | Seattle District Office | Insanitary Conditions/Adulterated | N/A * |
March 27, 2001 | Cucina Fresca Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
March 27, 2001 | Oregon Gourmet Crab Inc. | Seattle District Office | Seafood HACCP/Crab and Crab Sections | N/A * |
March 27, 2001 | Zeus Scientific Inc. | New Jersey District Office | IVD Test Kits/Reporting Requirements | N/A * |
March 26, 2001 | Jy-Ro Farm | Atlanta District Office | Dairy/Adulterated/Illegal Drug Residue | N/A * |
March 26, 2001 | St. Vincent's Hospital Comprehensive Breast Center | New Orleans District Office | Mammography Standards | N/A * |
March 23, 2001 | Purina Mills Inc | Dallas District Office | CGMP/Medicated Feeds/Adulterated | N/A * |
March 23, 2001 | Pioneer Express Respiratory Care Inc. | New Orleans District Office | GMP/Oxygen and Nitrogen Gases/Adulterated | N/A * |
March 23, 2001 | Cyberonics Inc. | Dallas District Office | Medical Device Reporting/NCP System/Misbranded | N/A * |
March 23, 2001 | Medina Landmark Inc. | Cincinnati District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
March 23, 2001 | Kephart Farms | Los Angeles District Office | Food/Dairy/Adulterated | N/A * |
March 23, 2001 | Jeppi Nut company Inc. | Baltimore District Office | Warehouse/Manufacturing Facility/Insanitary Conditions/Adulterated | N/A * |
March 23, 2001 | Centerburg Mill and General Store Inc | Cincinnati District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
March 23, 2001 | Sandhills Regional Medical Center | Atlanta District Office | Mammography Standards | N/A * |
March 22, 2001 | EHG Medical Group of Texas P.A. | Dallas District Office | Mammography Standards | N/A * |
March 22, 2001 | New Decade Laboratories Inc. | Minneapolis District Office | cGMP/Finished Pharmaceuticals/Veterinary Drug Manufacturing Facility | N/A * |
March 22, 2001 | River Valley Co-Op | Cincinnati District Office | Animal Proteins Prohibeted in Ruminant Feed | N/A * |
March 22, 2001 | Universal Nutrition Inc. | Center for Food Safety and Applied Nutrition | Unapproved Food Additives/LowCarb Bar/Misbranded/Adulterated | N/A * |
March 22, 2001 | Rudy Inc. | Cincinnati District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
March 21, 2001 | International Wholesalers Corporation | Baltimore District Office | Food Storage Warehouse/Insanitary Conditions/Adulterated | N/A * |
March 21, 2001 | Queens Open MRI | New York District Office | Mammography Standards | N/A * |
March 21, 2001 | Western Reserve Farm Cooperative | Cincinnati District Office | Animal Protein Prohibited in Ruminant Feed | N/A * |
March 21, 2001 | Central Triad Imaging Center | Atlanta District Office | Mammography Standards | N/A * |
March 21, 2001 | Morcher GmbH | Center for Devices and Radiological Health | Aniridia Implants/Adulterated/Lack Application for Premarket Approval | N/A * |
March 21, 2001 | Stewart's Farm Supply | Cincinnati District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
March 21, 2001 | Faler Feed Store Inc. | Cincinnati District Office | Animal Proteins Prohibited in Ruminant Feed | N/A * |
March 21, 2001 | Perris Medical Imaging Center Inc. | Los Angeles District Office | Mammography Standards | N/A * |
March 21, 2001 | Bulloch Memorial Hospital | Atlanta District Office | Mammography Standards | N/A * |
March 20, 2001 | Kowalke Family Sprouts | Los Angeles District Office | Sprouts/ Insanitary Conditions/Adulterated | N/A * |
March 20, 2001 | Imaex Trading Company Inc. | Atlanta District Office | Seafood HACCP/Frozen Raw Shrimp | N/A * |
March 20, 2001 | Medical Associates of Gallipolis Inc. | Cincinnati District Office | Mammography Standards | N/A * |
March 20, 2001 | 3D of Key West Inc. | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
March 20, 2001 | East Texas Medical Center - Quitman | Dallas District Office | Mammography Standards | N/A * |
March 20, 2001 | Allina Medical Clinic Administration | Minneapolis District Office | Mammography Standards | N/A * |
March 20, 2001 | Happy Valley Food Inc. | Baltimore District Office | Manufacturing/Warehousing Facility/Insanitary Conditions/Adulterated | N/A * |
March 20, 2001 | DeLonghi S.p.A. | Center for Devices and Radiological Health | Federal Performance Standard for Microwave Ovens/Electronic Product Radiation Controls | N/A * |
March 20, 2001 | Sprouters Northwest Inc. | Seattle District Office | CGMP/Manufacturing Packing & Holding Human Food | N/A * |
March 20, 2001 | Mid-Atlantic Diagnostics | New Jersey District Office | Quality System Regulation/The Stripper Micropipette with Tips | N/A * |
March 19, 2001 | Danatech Medical Systems Inc. | Florida District Office | Ultrasound Measuring Devices | N/A * |
March 19, 2001 | Sandwich City Company | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
March 16, 2001 | W & L International Group Inc. | Los Angeles District Office | Not Held Intact for Inspection | N/A * |
March 16, 2001 | Oxy-Stat Inc. Home Health Care | Florida District Office | Ulti-Lance/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
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