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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
02/26/2007 Nucare Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Qualitest Pharmaceuticals, Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 DSC Laboratories [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Centrix Pharmaceutical Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Kaiser Foundation Hosptials [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 IVAX Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Vintage Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Ferndale Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Bio Pharm Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Actavis Totowa LLC [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 De Vries Dairy Seattle District Office Illegal Drug Residue N/A *
02/26/2007 Harvard Drug Group [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 Murfreesboro Pharmaceutical Nursing Supply [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 SDA Laboratories [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/26/2007 DRX Pharmaceutical Consultants Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
02/23/2007 Niagara Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
02/23/2007 Portage Prairie Pastured Poultry [ARCHIVED] Detroit District Office PHS Act/Violation N/A *
02/22/2007 Seryx, Inc. [ARCHIVED] Center for Devices and Radiological Health Lack Approved New Drug Application/Misbranded N/A *
02/22/2007 GE Healthcare Technologies [ARCHIVED] Cincinnati District Office QSR/Medical Devices/Adulterated N/A *
02/22/2007 Medley Tomatoes, Inc. [ARCHIVED] Florida District Office Federal Food, Drug, and Cosmetic Act Violations N/A *
02/21/2007 Newport Medical Instruments, Inc. [ARCHIVED] Los Angeles District Office QSR/Medical Devices/Adulterated N/A *
02/21/2007 Maunesha River Dairy [ARCHIVED] Minneapolis District Office Illegal Drug Residue N/A *
02/17/2007 BioForm Medical, Inc. [ARCHIVED] Minneapolis District Office Labeling Drug Claims N/A *
02/16/2007 Uwajimaya, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated N/A *
02/15/2007 Martex Farms S.E. [ARCHIVED] San Juan District Office Juice HACCP/Adulterated N/A *
02/15/2007 Underwood, Hollis J.C., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
02/12/2007 Russell County Stockyards [ARCHIVED] Cincinnati District Office Inerstate Commerce/Food/Adulterated N/A *
02/09/2007 John, David E New York District Office Illegal Drug Residue N/A *
02/09/2007 Rymed Technologies, Inc. [ARCHIVED] Dallas District Office QSR/Medical Devices/Adulterated/Misbranded N/A *
02/08/2007 Forest Grove Dairy [ARCHIVED] Detroit District Office PHS Act/Violation N/A *
02/08/2007 Herron, Jerry M., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
02/07/2007 Mary Ellen Maryland Crab Meat Company, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated N/A *
02/07/2007 Syosset Seafoods Co [ARCHIVED] Dallas District Office Seafood HACCP N/A *
02/05/2007 Princess Brandy Co., Inc. [ARCHIVED] Los Angeles District Office CGMP/Foods/Insanitary Conditions N/A *
02/05/2007 Edwards Life Sciences, LLC [ARCHIVED] Los Angeles District Office CGMP/Quality System/Adulterated N/A *
02/05/2007 La Coruna Foods, inc. [ARCHIVED] San Juan District Office Seafood HACCP/Adulterated N/A *
02/02/2007 First Check Diagnostics, LLC [ARCHIVED] Los Angeles District Office QSR For Medical Device/Adulterated N/A *
02/02/2007 Fisher & Paykel Healthcare, Inc. [ARCHIVED] Los Angeles District Office CGMP/Quality System/Adulterated N/A *
02/02/2007 Medical Concepts Development [ARCHIVED] Minneapolis District Office CGMP/Quality System/Adulterated N/A *
02/01/2007 Patient Advocacy Council, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
02/01/2007 Hanover Foods Corporation [ARCHIVED] New Jersey District Office Food Labeling/False & Misleading/Misbranded N/A *
02/01/2007 Actavis Totowa, LLC [ARCHIVED] New Jersey District Office CGMP/Deviations/Adulterated N/A *
02/01/2007 Meadow Wood Animal Clinic New England District Office Illegal Drug Residue N/A *
01/30/2007 Congressional Seafood Co. [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
01/30/2007 Panini Ventures, LLC [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded N/A *
01/29/2007 Philips Medical Systems [ARCHIVED] Seattle District Office CGMP/Quality System/Adulterated N/A *
01/29/2007 University of Cincinnati College of Medicine [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
01/24/2007 Farmers Livestock Market of Glasgow Cincinnati District Office Illegal Drug Residue N/A *
01/24/2007 Wheaton Franciscan Healthcare [ARCHIVED] Center for Biologics Evaluation and Research Institutional Review Board (IRB) N/A *
01/24/2007 Good Flow Juice Company [ARCHIVED] Dallas District Office Juice/HACCP/Adulterated N/A *

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ICECI Warning Letters

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