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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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