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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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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
March 14, 2007 KSM, Inc. [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (Sponsor) 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 Investigational Device Exemptions (Sponsor) 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. [ARCHIVED] New England District Office Extralabel Drug /Approved Labeling/Adulterated 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 Clinical Investigator (Sponsor) 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 [ARCHIVED] Minneapolis District Office Animals for Sale for Slaughter as Food/Adulterated 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 *



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ICECI Warning Letters

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