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2006 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
08/08/2006 Seafood Marketing US, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
08/03/2006 Wallach Surgical Devices, Inc. [ARCHIVED] New England District Office Current Good Manufacturing Requirements for Medical Devices/Adulterated N/A *
08/03/2006 Blue Sea Import Corporation [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
08/03/2006 E-Fish Network Corporation [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
08/02/2006 ParaDevices [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
08/02/2006 Women's Breast Care Clinic [ARCHIVED] New Orleans District Office Mammography Quality Standards Act N/A *
08/02/2006 Medelle Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
08/02/2006 Toby's Nose Filters, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
08/01/2006 Peters, Anthony [ARCHIVED] Detroit District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
07/31/2006 Central Boeki USA Ltd [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
07/28/2006 At Last Gourmet Foods [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated N/A *
07/27/2006 Safeway Industries [ARCHIVED] Minneapolis District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
07/27/2006 BioGenex Laboratories [ARCHIVED] San Francisco District Office Quality System Regulation for Medical Devices/Adulterated N/A *
07/24/2006 Sheffield Laboratories, Div. of Faria Limited, LLC [ARCHIVED] New England District Office CGMP/Finished Pharmaceuticals/Adulterated N/A *
07/21/2006 Tyco Healthcare/Kendall [ARCHIVED] Center for Devices and Radiological Health Lack Approved Premarket Application/Adulterated/Misbranded N/A *
07/21/2006 Betterthanair, LLC [ARCHIVED] Denver District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
07/20/2006 Medisurg Research & Management Corporation [ARCHIVED] Philadelphia District Office CGMP Requirements for Medical Devices/Adulterated N/A *
07/20/2006 Teleflex Incorporated [ARCHIVED] Atlanta District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
07/19/2006 Frad 35, Inc [ARCHIVED] Dallas District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
07/19/2006 Boulder Natural Labs, LLC [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading Claims/New Drug/Misbranded N/A *
07/19/2006 DFWX [ARCHIVED] Dallas District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
07/18/2006 Royalston Foods [ARCHIVED] Minneapolis District Office Color Additive/Adulterated/Misbranded N/A *
07/18/2006 National Honey, Inc., dba National Commodities, Co [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
07/17/2006 Injex-Equidyne Systems, Inc. [ARCHIVED] Los Angeles District Office QSR/Medical Devices/Adulterated N/A *
07/17/2006 HNS International, Inc. [ARCHIVED] Los Angeles District Office QSR/Medical Devices/Adulterated N/A *
07/17/2006 Ultrasonic Services, Inc [ARCHIVED] Dallas District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
07/14/2006 Bose, William J., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
07/13/2006 Grinalat Foods Corporation [ARCHIVED] Chicago District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
07/13/2006 Western Illinois Grain Co. [ARCHIVED] Chicago District Office CGMP Requirements For Medicated Feeds/Adulterated N/A *
07/13/2006 Advanced Medical Systems, Inc. [ARCHIVED] New Orleans District Office Premarket Approval/Misbranded/Adulterated N/A *
07/12/2006 Herbal Remedies [ARCHIVED] Denver District Office False & Misleading Claims/New Drug/Misbranded N/A *
07/12/2006 Good, Cheryl [ARCHIVED] New Orleans District Office Labeling/False & Misleading Claims/Misbranded N/A *
07/11/2006 Actra-Rx [ARCHIVED] Los Angeles District Office False & Misleading Claims/New Drug/Misbranded N/A *
07/11/2006 OSU Corporation [ARCHIVED] Los Angeles District Office Promotional Claims/New Drug/Misbranded N/A *
07/11/2006 Concord Laboratories, Inc [ARCHIVED] New Jersey District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
07/11/2006 Baugher Enterprise, Inc. [ARCHIVED] Baltimore District Office Juice HACCP/Adulterated N/A *
07/11/2006 Cardiac Science Corporation [ARCHIVED] Minneapolis District Office CGMP for Medical Devices/Adulterated N/A *
07/11/2006 Sargent, Robert [ARCHIVED] New York District Office False & Misleading Claims/New Drug/Misbranded N/A *
07/11/2006 Herbin Tonics LLC [ARCHIVED] Los Angeles District Office False & Misleading Claims/New Drug/Misbranded N/A *
07/11/2006 Access Financial Market [ARCHIVED] Minneapolis District Office False & Misleading Claims/New Drug/Misbranded N/A *
07/11/2006 ATCSF Inc [ARCHIVED] San Francisco District Office False & Misleading Claims/New Drug/Misbranded N/A *
07/10/2006 Care Products Inc [ARCHIVED] Dallas District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
07/10/2006 Jeff's Gourmet Pies, Inc. [ARCHIVED] Florida District Office Food Labeling/Misbranded N/A *
07/10/2006 Choraphor.com [ARCHIVED] Seattle District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
07/10/2006 Parnell Pharmaceuticals, Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application/Misbranded N/A *
07/10/2006 Oklahoma Blood Institute Institutional Review Board [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
07/10/2006 International Biophysics Corporation [ARCHIVED] Dallas District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
07/07/2006 Higher Power, Inc [ARCHIVED] Seattle District Office Labeling/Dietary Supplements/False & Misleading Claims/New Drug N/A *
07/07/2006 Roha U.S.A., LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Color Additives Certification N/A *
07/06/2006 Stachniw, Myron B., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *

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ICECI Warning Letters

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