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U.S. Department of Health and Human Services

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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
July 10, 2001 EP MedSystems [ARCHIVED] New Jersey District Office Quality System Regulation/Cardiac Catheters/Adulterated N/A *
July 09, 2001 World Diagnostics, Inc. [ARCHIVED] Florida District Office Lacks Application for Premarket Approval/IDE Exemption/Lacks Export Authority N/A *
July 09, 2001 Henry Mayo Newhall Memorial Hospital [ARCHIVED] Los Angeles District Office Mammography Quality Standards N/A *
July 09, 2001 American Eagle Airlines, Inc. [ARCHIVED] Dallas District Office Interstate Conveyance Sanitation Regulations N/A *
July 09, 2001 SciOptic International Center for Devices and Radiological Health Sponsor Obligations N/A *
July 07, 2001 Centura Health Avista Hospital [ARCHIVED] Dallas District Office Mammography Quality Standards N/A *
July 06, 2001 Nesbitt, Lori A., Pharm. D., M.B.A. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
July 06, 2001 Aultman Health Foundation [ARCHIVED] Cincinnati District Office Good Manufacturing Practices for Blood and Blood Products N/A *
July 06, 2001 Heinig, Robert E., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
July 06, 2001 Ferro Corporation [ARCHIVED] Chicago District Office CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
July 05, 2001 OBGYN Associates of the Southern Tier [ARCHIVED] New York District Office Mammography Quality Standards N/A *
July 05, 2001 Herolds Salads, Inc. [ARCHIVED] Cincinnati District Office Seafood HACCP/Good Manufacturing Practice Regulations N/A *
July 05, 2001 Sedecal SA [ARCHIVED] Center for Devices and Radiological Health Lacks Submission Product Substantially Equivalent/Misbranded N/A *
July 03, 2001 Frenchy's Seafood Company [ARCHIVED] Florida District Office Seafood HACCP N/A *
July 02, 2001 J-Rob Farms, Inc. [ARCHIVED] New York District Office Animal Drug/Adulterated N/A *
July 02, 2001 Brown Bag Sandwiches, Inc. [ARCHIVED] Los Angeles District Office Food Handling & Sanitation Practice/Bacterial Contamination/Adulterated N/A *
July 02, 2001 True Worlds Foods, Inc - Rocky Neck Seafoods [ARCHIVED] New England District Office Seafood HACCP N/A *
July 02, 2001 Blackburn Brothers, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP N/A *
July 02, 2001 Meridian Pharmaceuticals, Inc. [ARCHIVED] New Orleans District Office Active Pharmaceutical Ingredients, Repackaging, Relabeling/Adulterated N/A *
July 02, 2001 O & L Dairy #2 [ARCHIVED] Los Angeles District Office Illegal Drug Tissue Residue/Adulterated N/A *



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ICECI Warning Letters

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