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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2007 Warning Letters

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Tobacco Retailer 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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 27, 2007 Traina, Steve M., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 27, 2007 Eury, Edward J., Jr. Baltimore District Office Illegal Drug Residue N/A *
July 26, 2007 Rogers Farm New England District Office Illegal Drug Residue N/A *
July 26, 2007 Eidam Diagnostics Corporation [ARCHIVED] Center for Devices and Radiological Health Device Labeling/Quality System Regulation/Misbranded/Adulterated N/A *
July 25, 2007 Pharmaceutical Laboratories and Consultants, Inc. [ARCHIVED] Chicago District Office Current Good Manufacturing Practice/Adulterated N/A *
July 24, 2007 Gebauer Company [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 23, 2007 Miami Terminal Cold Storage, LLC [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
July 18, 2007 Louisville APL Diagnostics, Inc. [ARCHIVED] Dallas District Office Device/Adulterated N/A *
July 17, 2007 Nanogen Point-of-Care Diagnostic Division [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
July 16, 2007 Overland Park Regional Medical Center [ARCHIVED] Kansas City District Office CGMP/Deviations/Adulterated N/A *
July 13, 2007 Quality Formulation Laboratories, Inc. [ARCHIVED] New Jersey District Office Food Labeling/Adulterated N/A *
July 11, 2007 Schering-Plough Animal Health Corporation [ARCHIVED] Center for Veterinary Medicine Promotional Claims/False & Misleading/Misbranded N/A *
July 11, 2007 Blue Star Fish Company [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
July 11, 2007 International Seaworld, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
July 10, 2007 Foo Yuan Food Products Co., Inc [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
July 10, 2007 Farmers Market of Bolivar, Missouri, Inc. [ARCHIVED] Kansas City District Office Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
July 10, 2007 Juice Company, LLC [ARCHIVED] Florida District Office Juice HACCP/Adulterated N/A *
July 09, 2007 First Priority, Inc. [ARCHIVED] Chicago District Office CGMP Regulation for Finished Pharmaceuticals/Adulterated N/A *
July 05, 2007 Ham Produce and Seafood, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
July 03, 2007 Linden, David, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
July 03, 2007 Janssen, Michael E., DO [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
July 03, 2007 Medtronic, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 01, 2007 T.W. Enterprises, Inc. [ARCHIVED] Seattle District Office Adulterated Food N/A *
June 29, 2007 ZEO Health Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition New Drugs/Claims N/A *
June 27, 2007 George's Fish and Seafood [ARCHIVED] Dallas District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
June 26, 2007 J & T Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
June 26, 2007 Staar Surgical Company [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
June 26, 2007 Elanco Animal Health [ARCHIVED] Center for Veterinary Medicine Sponsor/Monitor/Contract Research Organization N/A *
June 26, 2007 Preferred Freezer Services, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated N/A *
June 25, 2007 Sitek Research Laboratories [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) N/A *
June 25, 2007 J & J Seafood, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
June 25, 2007 Innovative Spinal Technologies, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 22, 2007 Wingrove, Frank A., D.D.S. [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
June 21, 2007 Merial Limited [ARCHIVED] Center for Veterinary Medicine Promotional Claims/New Drug/Misbranded N/A *
June 19, 2007 JC's Fish and BBQ, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
June 19, 2007 Bodin's, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 19, 2007 Biomedicare, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 19, 2007 S & W Farms [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
June 14, 2007 Crystal Reflections International, Inc. [ARCHIVED] Los Angeles District Office CGMP for Medical Devices/QS/Adulterated N/A *
June 12, 2007 Tingle X-Ray Products, Inc. [ARCHIVED] New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
June 11, 2007 Bayer Health Care LLC [ARCHIVED] Center for Veterinary Medicine Promotional Claims/False & Misleading/Misbranded N/A *
June 08, 2007 Medion Diagnostic AG [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
June 06, 2007 Biolog, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
June 06, 2007 Number One Fish Market Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
June 06, 2007 Kevin Sharpe Farm [ARCHIVED] New York District Office Illegal Drug Residue N/A *
June 05, 2007 Heska Corporation [ARCHIVED] Center for Veterinary Medicine Promotional Claims False & Misleading/Misbranded N/A *
June 05, 2007 Hand, Steve, M Atlanta District Office Illegal Drug Residue N/A *
June 04, 2007 Truluck's Seafood LTD [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 01, 2007 TheraLife, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
June 01, 2007 Dornier Medtech America, Inc. [ARCHIVED] Atlanta District Office Medical Device Reporting Regulation/Misbranded N/A *

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ICECI Warning Letters

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Food and Drug Administration

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