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U.S. Department of Health and Human Services

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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
August 09, 2006 Pascal Company, Inc. [ARCHIVED] Seattle District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
August 09, 2006 CCS Medical [ARCHIVED] Florida District Office Pharmacy Compounding/Unapproved New Drug/Misbranded N/A *
August 08, 2006 Sonotech, Incorporated [ARCHIVED] Seattle District Office Quality System Regulation/Medical Device Reporting/Adulterated N/A *
August 08, 2006 Seafood Marketing US, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Adulterated N/A *
August 03, 2006 Wallach Surgical Devices, Inc. [ARCHIVED] New England District Office Current Good Manufacturing Requirements for Medical Devices/Adulterated N/A *
August 03, 2006 Blue Sea Import Corporation [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
August 03, 2006 E-Fish Network Corporation [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
August 02, 2006 ParaDevices [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
August 02, 2006 Women's Breast Care Clinic [ARCHIVED] New Orleans District Office Mammography Quality Standards Act N/A *
August 02, 2006 Medelle Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
August 02, 2006 Toby's Nose Filters, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
August 01, 2006 Peters, Anthony [ARCHIVED] Detroit District Office Labeling/Promotional Claims False & Misleading/New Drug N/A *
July 31, 2006 Central Boeki USA Ltd [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
July 28, 2006 At Last Gourmet Foods [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated N/A *
July 27, 2006 Safeway Industries [ARCHIVED] Minneapolis District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
July 27, 2006 BioGenex Laboratories [ARCHIVED] San Francisco District Office Quality System Regulation for Medical Devices/Adulterated N/A *
July 24, 2006 Sheffield Laboratories, Div. of Faria Limited, LLC [ARCHIVED] New England District Office CGMP/Finished Pharmaceuticals/Adulterated N/A *
July 21, 2006 Tyco Healthcare/Kendall [ARCHIVED] Center for Devices and Radiological Health Lack Approved Premarket Application/Adulterated/Misbranded N/A *
July 21, 2006 Betterthanair, LLC [ARCHIVED] Denver District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
July 20, 2006 Medisurg Research & Management Corporation [ARCHIVED] Philadelphia District Office CGMP Requirements for Medical Devices/Adulterated N/A *
July 20, 2006 Teleflex Incorporated [ARCHIVED] Atlanta District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
July 19, 2006 Frad 35, Inc [ARCHIVED] Dallas District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
July 19, 2006 Boulder Natural Labs, LLC [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading Claims/New Drug/Misbranded N/A *
July 19, 2006 DFWX [ARCHIVED] Dallas District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
July 18, 2006 Royalston Foods [ARCHIVED] Minneapolis District Office Color Additive/Adulterated/Misbranded N/A *
July 18, 2006 National Honey, Inc., dba National Commodities, Co [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
July 17, 2006 Injex-Equidyne Systems, Inc. [ARCHIVED] Los Angeles District Office QSR/Medical Devices/Adulterated N/A *
July 17, 2006 HNS International, Inc. [ARCHIVED] Los Angeles District Office QSR/Medical Devices/Adulterated N/A *
July 17, 2006 Ultrasonic Services, Inc [ARCHIVED] Dallas District Office Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
July 14, 2006 Bose, William J., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
July 13, 2006 Grinalat Foods Corporation [ARCHIVED] Chicago District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
July 13, 2006 Western Illinois Grain Co. [ARCHIVED] Chicago District Office CGMP Requirements For Medicated Feeds/Adulterated N/A *
July 13, 2006 Advanced Medical Systems, Inc. [ARCHIVED] New Orleans District Office Premarket Approval/Misbranded/Adulterated N/A *
July 12, 2006 Herbal Remedies [ARCHIVED] Denver District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 12, 2006 Good, Cheryl [ARCHIVED] New Orleans District Office Labeling/False & Misleading Claims/Misbranded N/A *
July 11, 2006 Actra-Rx [ARCHIVED] Los Angeles District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 11, 2006 OSU Corporation [ARCHIVED] Los Angeles District Office Promotional Claims/New Drug/Misbranded N/A *
July 11, 2006 Concord Laboratories, Inc [ARCHIVED] New Jersey District Office Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated N/A *
July 11, 2006 Baugher Enterprise, Inc. [ARCHIVED] Baltimore District Office Juice HACCP/Adulterated N/A *
July 11, 2006 Cardiac Science Corporation [ARCHIVED] Minneapolis District Office CGMP for Medical Devices/Adulterated N/A *
July 11, 2006 Sargent, Robert [ARCHIVED] New York District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 11, 2006 Herbin Tonics LLC [ARCHIVED] Los Angeles District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 11, 2006 Access Financial Market [ARCHIVED] Minneapolis District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 11, 2006 ATCSF Inc [ARCHIVED] San Francisco District Office False & Misleading Claims/New Drug/Misbranded N/A *
July 10, 2006 Care Products Inc [ARCHIVED] Dallas District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *
July 10, 2006 Jeff's Gourmet Pies, Inc. [ARCHIVED] Florida District Office Food Labeling/Misbranded N/A *
July 10, 2006 Choraphor.com [ARCHIVED] Seattle District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
July 10, 2006 Parnell Pharmaceuticals, Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application/Misbranded N/A *
July 10, 2006 Oklahoma Blood Institute Institutional Review Board [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
July 10, 2006 International Biophysics Corporation [ARCHIVED] Dallas District Office CGMP for Medical Devices/Medical Device Reporting/Adulterated N/A *

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ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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