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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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Warning Letters for 2007

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
February 26, 2007 SDA Laboratories [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 *
February 26, 2007 Nucare Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Qualitest Pharmaceuticals, Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 DSC Laboratories [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Centrix Pharmaceutical Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Kaiser Foundation Hosptials [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 IVAX Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Vintage Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Ferndale Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Bio Pharm Inc. [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 26, 2007 Actavis Totowa LLC [ARCHIVED] Center for Drug Evaluation and Research Marketing an unapproved new drug - ergotamine tartrate N/A *
February 23, 2007 Portage Prairie Pastured Poultry [ARCHIVED] Detroit District Office PHS Act/Violation N/A *
February 23, 2007 Niagara Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
February 22, 2007 Seryx, Inc. [ARCHIVED] Center for Devices and Radiological Health Lack Approved New Drug Application/Misbranded N/A *



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ICECI Warning Letters

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Food and Drug Administration

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