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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
May 19, 2009 Perelandra, LTD Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 19, 2009 Jes-Made Bakery Philadelphia District Office Labeling N/A *
May 19, 2009 GlycoMeds, LLC Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 19, 2009 Nature's Health Supply Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 18, 2009 Storz Endoskop GMBH Center for Devices and Radiological Health Current Good Manufacturing Practice for Medical Devices/Adulterated N/A *
May 18, 2009 NZYMES.COM Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 15, 2009 Healing Edge Science Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Viral Defender Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Allerair Industries Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Luminex Corporation Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Resolveswineflu.com USA Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Galloway Safety and Supply Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Nova Computers dba Nova Tech Gadgets Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Skilling Institute Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Huntington Beach Sunset Inc. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 14, 2009 Baptist Medical Center Dallas District Office CGMP for Blood & Blood Components/Adulterated N/A *
May 13, 2009 911 Water Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 13, 2009 Breathe More Easily Online Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 13, 2009 Sanuvox Technologies Inc. 5/13/09 Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 13, 2009 Emergency Disaster Systems Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *



 

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ICECI Warning Letters

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