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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 ffrench Pocket Airway, Inc. New Orleans District Office Investigational Device Exemptions N/A *
June 04, 2009 Seacoast Natural Foods, Inc Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 04, 2009 UVHealth Direct, LLC Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 04, 2009 American Ultraviolet Co. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 02, 2009 InspiredLiving.com Seattle District Office New Drugs, Unapproved/Labeling/Misbranded N/A *
June 02, 2009 Field Controls, LLC Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 02, 2009 Circular Enterprises, LLC Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 02, 2009 Coberg, Inc. Los Angeles District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated N/A *
June 02, 2009 Pet Kiss Inc. Los Angeles District Office New Animal Drug Application N/A *
June 02, 2009 Atrium Innovation Limited Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 01, 2009 Gordon, Mark, M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
June 01, 2009 Medtronic Puerto Rico Operations Company San Juan District Office CGMP/QSR/Medical Device/Adulterated N/A *
May 29, 2009 Fitura, LLC Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 29, 2009 Performance Brand Flucinex Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 29, 2009 Boles Livestock Denver District Office Illegal Drug Residue N/A *
May 29, 2009 UltraRad Corporation Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
May 29, 2009 Reynolds, Newton J. New England District Office Illegal Drug Residue N/A *
May 29, 2009 Bioset Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 29, 2009 Simple Clinic, Inc. 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 New Orleans District Office CGMP Regulation For Food/Adulterated N/A *



 

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ICECI Warning Letters

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