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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
April 09, 2007 Clark Research and Development, Inc. [ARCHIVED] New Orleans District Office Current Good Manufacturing Practice for Medical Devices N/A *
April 04, 2007 Redux Beverages, LLC [ARCHIVED] Los Angeles District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded N/A *
April 04, 2007 Drew Scientific Co. Limited [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice/Adulterated N/A *
April 03, 2007 Davis, Thomas P, M.D. [ARCHIVED] Center for Devices and Radiological Health Sponsor-Investigator N/A *
April 03, 2007 Iren Corporation [ARCHIVED] Philadelphia District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
April 02, 2007 LifeCare Technologies, Inc. [ARCHIVED] Florida District Office QSR/Medical Devices/Misbranded N/A *
March 30, 2007 Everything Spelt Company, Inc. [ARCHIVED] New York District Office False & Misleading Claims/Misbranded N/A *
March 30, 2007 ViroMed Laboratories [ARCHIVED] Minneapolis District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
March 29, 2007 Chambers, Edward M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
March 29, 2007 D.B.I. America Corp [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 29, 2007 Akorn, Incorporated [ARCHIVED] Chicago District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
March 29, 2007 Thiele Dairy Kansas City District Office Illegal Drug Residue N/A *
March 29, 2007 Freedom Plus Corporation [ARCHIVED] San Francisco District Office Dietary Supplement/Adulterated N/A *
March 28, 2007 Sleep Devices, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 26, 2007 Rockland Farm [ARCHIVED] New England District Office Illegal Drug Residue N/A *
March 26, 2007 Clearview Dairy, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
March 26, 2007 Chi Global Foods System, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP N/A *
March 23, 2007 Sigma International General Medical Apparatus, LLC [ARCHIVED] New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 23, 2007 Gloucester Seafood, Inc. [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
March 23, 2007 Neotropix, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Good Laboratory Practice (GLP) N/A *
March 22, 2007 Access Point Medical LLC [ARCHIVED] Kansas City District Office Federal Food, Drug and Cosmetic Act Violations N/A *
March 22, 2007 Madera Calf Ranch [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
March 21, 2007 ComputeRx/Broncho-Dose, Ltd. [ARCHIVED] New England District Office Federal Food, Drug and Cosmetic Act Violations N/A *
March 21, 2007 Bentec Medical, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
March 19, 2007 Fairmont Dairy LLC [ARCHIVED] New England District Office Illegal Drug Residue N/A *
March 15, 2007 Nich Marketers Inc. [ARCHIVED] Cincinnati District Office Labeling & Promotional Materials N/A *
March 15, 2007 Stryker Ireland, Ltd., Orthopaedics [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
March 14, 2007 Freeport Health Network IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
March 14, 2007 KSM, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
March 13, 2007 Abbott Laboratories, Inc. [ARCHIVED] Dallas District Office QSR/Medical Devices/Adulterated/Misbranded N/A *
March 13, 2007 Cochlear Americas [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
March 12, 2007 St. Joseph's Candler-Mobile Mammography [ARCHIVED] Atlanta District Office Mammography Quality Standards N/A *
March 09, 2007 Fairmont Farm Inc. New England District Office Illegal Drug Residue N/A *
March 07, 2007 Tres Leches Factory [ARCHIVED] San Juan District Office Food Labeling/Misbranded N/A *
March 05, 2007 BSD Medical Corporation [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
March 05, 2007 J & D Wilson & Sons Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
March 02, 2007 Beehive Botanicals, Inc. [ARCHIVED] Minneapolis District Office Dietary Supplements N/A *
March 02, 2007 North American Medical Corporation [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
March 01, 2007 Pacific International Seafood, LLC [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated N/A *
March 01, 2007 Trestle Corporation [ARCHIVED] Center for Devices and Radiological Health No Premarket Approval/Adulterated/Misbranded N/A *
February 28, 2007 Murray, Robert Mitchell M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
February 28, 2007 Lanners, Rogers Minneapolis District Office Illegal Drug Residue N/A *
February 27, 2007 BTI Filtration [ARCHIVED] Dallas District Office QSR For Medical Device/Adulterated N/A *
February 26, 2007 Breckenridge Pharmaceutical Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Sandoz Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Lini Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Superior Pharmaceutical Company [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Excellium Pharmaceutical Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 United Research Laboratories Inc. and Mutual Pharmaceutical Company [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Anabolic Laboratories [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *

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ICECI Warning Letters

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