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U.S. Department of Health and Human Services

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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
07/27/2007 Traina, Steve M., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
07/27/2007 Eury, Edward J., Jr. Baltimore District Office Illegal Drug Residue N/A *
07/26/2007 Rogers Farm New England District Office Illegal Drug Residue N/A *
07/26/2007 Eidam Diagnostics Corporation [ARCHIVED] Center for Devices and Radiological Health Device Labeling/Quality System Regulation/Misbranded/Adulterated N/A *
07/25/2007 Pharmaceutical Laboratories and Consultants, Inc. [ARCHIVED] Chicago District Office Current Good Manufacturing Practice/Adulterated N/A *
07/24/2007 Gebauer Company [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/23/2007 Miami Terminal Cold Storage, LLC [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
07/18/2007 Louisville APL Diagnostics, Inc. [ARCHIVED] Dallas District Office Device/Adulterated N/A *
07/17/2007 Nanogen Point-of-Care Diagnostic Division [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
07/16/2007 Overland Park Regional Medical Center [ARCHIVED] Kansas City District Office CGMP/Deviations/Adulterated N/A *
07/13/2007 Quality Formulation Laboratories, Inc. [ARCHIVED] New Jersey District Office Food Labeling/Adulterated N/A *
07/11/2007 Schering-Plough Animal Health Corporation [ARCHIVED] Center for Veterinary Medicine Promotional Claims/False & Misleading/Misbranded N/A *
07/11/2007 Blue Star Fish Company [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
07/11/2007 International Seaworld, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
07/10/2007 Foo Yuan Food Products Co., Inc [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
07/10/2007 Farmers Market of Bolivar, Missouri, Inc. [ARCHIVED] Kansas City District Office Good Manufacturing Practice for Medicated Feeds/Adulterated N/A *
07/10/2007 Juice Company, LLC [ARCHIVED] Florida District Office Juice HACCP/Adulterated N/A *
07/09/2007 First Priority, Inc. [ARCHIVED] Chicago District Office CGMP Regulation for Finished Pharmaceuticals/Adulterated N/A *
07/05/2007 Ham Produce and Seafood, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
07/03/2007 Linden, David, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
07/03/2007 Janssen, Michael E., DO [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
07/03/2007 Medtronic, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
07/01/2007 T.W. Enterprises, Inc. [ARCHIVED] Seattle District Office Adulterated Food N/A *
06/29/2007 ZEO Health Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition New Drugs/Claims N/A *
06/27/2007 George's Fish and Seafood [ARCHIVED] Dallas District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
06/26/2007 J & T Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
06/26/2007 Staar Surgical Company [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
06/26/2007 Elanco Animal Health [ARCHIVED] Center for Veterinary Medicine Sponsor/Monitor/Contract Research Organization N/A *
06/26/2007 Preferred Freezer Services, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated N/A *
06/25/2007 Sitek Research Laboratories [ARCHIVED] Center for Drug Evaluation and Research Good Laboratory Practice (GLP) N/A *
06/25/2007 J & J Seafood, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
06/25/2007 Innovative Spinal Technologies, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
06/22/2007 Wingrove, Frank A., D.D.S. [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
06/21/2007 Merial Limited [ARCHIVED] Center for Veterinary Medicine Promotional Claims/New Drug/Misbranded N/A *
06/19/2007 JC's Fish and BBQ, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
06/19/2007 Bodin's, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
06/19/2007 Biomedicare, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
06/19/2007 S & W Farms [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
06/14/2007 Crystal Reflections International, Inc. [ARCHIVED] Los Angeles District Office CGMP for Medical Devices/QS/Adulterated N/A *
06/12/2007 Tingle X-Ray Products, Inc. [ARCHIVED] New Orleans District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
06/11/2007 Bayer Health Care LLC [ARCHIVED] Center for Veterinary Medicine Promotional Claims/False & Misleading/Misbranded N/A *
06/08/2007 Medion Diagnostic AG [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
06/06/2007 Number One Fish Market Inc. [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
06/06/2007 Kevin Sharpe Farm [ARCHIVED] New York District Office Illegal Drug Residue N/A *
06/05/2007 Heska Corporation [ARCHIVED] Center for Veterinary Medicine Promotional Claims False & Misleading/Misbranded N/A *
06/05/2007 Hand, Steve, M Atlanta District Office Illegal Drug Residue N/A *
06/04/2007 Truluck's Seafood LTD [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
06/01/2007 TheraLife, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
06/01/2007 Dornier Medtech America, Inc. [ARCHIVED] Atlanta District Office Medical Device Reporting Regulation/Misbranded N/A *
06/01/2007 ImmuCell Corporation [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *

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ICECI Warning Letters

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