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

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ICECI Warning Letters

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