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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
12/27/2007 Mullet, Ivan New York District Office Illegal Drug Residue N/A *
12/27/2007 Absolutely Fresh Seafood Company [ARCHIVED] Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
12/21/2007 Medical Device Resource Corporation [ARCHIVED] San Francisco District Office Premarket Approval/Misbranded/Adulterated N/A *
12/21/2007 Ambassador Meat Distributors Inc [ARCHIVED] Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
12/21/2007 Cemac Foods Corporation [ARCHIVED] Philadelphia District Office CGMP/Misbranded N/A *
12/21/2007 Northwest Medical Physics Equipment, Inc. [ARCHIVED] Seattle District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
12/20/2007 Universal Enterprises Inc dba Air Service Hawaii [ARCHIVED] San Francisco District Office Interstate Conveyance Sanitation Regulations/Provisional N/A *
12/19/2007 Abbott Vascular, Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Devices/Adulterated/Misbranded N/A *
12/18/2007 Keystone Food Products Inc [ARCHIVED] Philadelphia District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions N/A *
12/18/2007 P-Ryton Corporation [ARCHIVED] New York District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
12/17/2007 Siemens Medical Solutions, Ultrasound Division [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
12/13/2007 G. Dundas Company Inc [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
12/13/2007 Moisan Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
12/07/2007 Spinal, USA [ARCHIVED] New Orleans District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
12/07/2007 Polychrome Medical, Inc [ARCHIVED] Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
12/05/2007 Wheatley, Susan J., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
12/04/2007 Wild Edibles, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
12/04/2007 G.D. Mathews and Sons Corporation dba Mathews Salad House Food Products [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
12/04/2007 Wild Edibles, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
12/03/2007 Pacific Consolidated Industries LLC [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated N/A *
11/30/2007 Avicenna Laser Technology Inc [ARCHIVED] Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
11/30/2007 Barnacle Seafod, Inc. [ARCHIVED] Florida District Office Seafood HAACP/CGMP for Foods/Adulterated N/A *
11/29/2007 E-Med Future, Inc. [ARCHIVED] Cincinnati District Office Devices/Quality System Regulation N/A *
11/28/2007 Stryker Orthopaedics Corp. [ARCHIVED] New Jersey District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
11/28/2007 Precision Biometrics, Inc. [ARCHIVED] Center for Devices and Radiological Health Device/Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
11/26/2007 Glenn Foods, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling Regulation N/A *
11/21/2007 Venosan North America [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting N/A *
11/21/2007 GlaxoSmithKline [ARCHIVED] Center for Drug Evaluation and Research Drug Labeling/Promotional Claims/Misbranded N/A *
11/19/2007 Winchester Bay Fisheries, LLC [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
11/19/2007 Imperial Trading Company, Inc. [ARCHIVED] New Orleans District Office CGMP For Manufacturing, Packing, or Holding Human Food N/A *
11/16/2007 GE Healthcare/General Electric Company [ARCHIVED] Minneapolis District Office Devices/X-ray Equipment N/A *
11/16/2007 Custom Assemblies, Inc. [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
11/16/2007 Ben Venue Laboratories, Inc. [ARCHIVED] Cincinnati District Office CGMP/Deviations/Adulterated N/A *
11/14/2007 Visser Ranch [ARCHIVED] Denver District Office Illegal Drug Residue N/A *
11/14/2007 Simco Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
11/09/2007 Nurse Assist, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
11/07/2007 C.V. Indotropic Fishery [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *
11/07/2007 Amerifit Brands, Inc [ARCHIVED] New England District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded N/A *
11/07/2007 Marjon Specialty Food, Inc [ARCHIVED] Florida District Office CGMP/Misbranded N/A *
11/06/2007 Ole' Mexican Foods, Inc. [ARCHIVED] Atlanta District Office Promotional Claims False & Misleading/Misbranded N/A *
11/02/2007 Fisheries Research Laboratory- SIU-C [ARCHIVED] Center for Veterinary Medicine Good Laboratory Practice (GLP) N/A *
11/01/2007 Troy Innovative Instruments, Inc. [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/QS/Adulterated N/A *
10/31/2007 Northeast General Pharmaceutical Factory [ARCHIVED] Center for Drug Evaluation and Research Current Good Manufacturing Practice Regulation/Adulterated N/A *
10/31/2007 Belford Seafood Co-Op [ARCHIVED] New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
10/30/2007 VAN Oriental Food, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
10/30/2007 A La Carte Foods, Inc. [ARCHIVED] New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
10/30/2007 International Technidyne Corporation [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Device Reporting/Adulterated N/A *
10/30/2007 Cytosol Laboratories, Inc. [ARCHIVED] New England District Office CGMP/Deviations/Adulterated N/A *
10/30/2007 Chung's Products, LP [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
10/29/2007 VDS Farms, L.L.C. [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *

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