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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 27, 2001 Tri County Hospital Minneapolis District Office Mammography Standards 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 Medina Landmark 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 23, 2001 Centerburg Mill and General Store Inc Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed 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 Jeppi Nut company Inc. Baltimore District Office Warehouse/Manufacturing Facility/Insanitary Conditions/Adulterated N/A *
March 23, 2001 Purina Mills Inc Dallas District Office CGMP/Medicated Feeds/Adulterated N/A *
March 23, 2001 Kephart Farms Los Angeles District Office Food/Dairy/Adulterated 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 River Valley Co-Op Cincinnati District Office Animal Proteins Prohibeted in Ruminant Feed N/A *
March 22, 2001 EHG Medical Group of Texas P.A. Dallas District Office Mammography Standards N/A *
March 22, 2001 Rudy Inc. Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed N/A *
March 22, 2001 New Decade Laboratories Inc. Minneapolis District Office cGMP/Finished Pharmaceuticals/Veterinary Drug Manufacturing Facility 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 *



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ICECI Warning Letters

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