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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
June 05, 2009 Frantz Design, Inc [ARCHIVED] Dallas District Office CGMP/QSR/Medical Device Reporting/Misbranded N/A *
June 05, 2009 The South Bend Chocolate Company, Inc. [ARCHIVED] Detroit District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
June 05, 2009 ffrench Pocket Airway, Inc. [ARCHIVED] New Orleans District Office Investigational Device Exemptions N/A *
June 04, 2009 UVHealth Direct, LLC [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 04, 2009 American Ultraviolet Co. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 04, 2009 Seacoast Natural Foods, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 02, 2009 Circular Enterprises, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 02, 2009 Field Controls, LLC [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 02, 2009 InspiredLiving.com [ARCHIVED] Seattle District Office New Drugs, Unapproved/Labeling/Misbranded N/A *
June 02, 2009 Pet Kiss Inc. [ARCHIVED] Los Angeles District Office New Animal Drug Application N/A *
June 02, 2009 Atrium Innovation Limited [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 02, 2009 Coberg, Inc. [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated N/A *
June 02, 2009 DS Waters of America, LP 6/2/09 [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded N/A *
June 01, 2009 Gordon, Mark, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
June 01, 2009 Medtronic Puerto Rico Operations Company [ARCHIVED] San Juan District Office CGMP/QSR/Medical Device/Adulterated N/A *
May 29, 2009 Simple Clinic, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 29, 2009 Bioset [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 29, 2009 Fitura, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 29, 2009 Won Feng Trading Inc [ARCHIVED] New Orleans District Office CGMP Regulation For Food/Adulterated N/A *
May 29, 2009 Performance Brand Flucinex [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *



 

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