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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 28, 2009 Amrita Aromatherapy, Inc Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 28, 2009 Inhalation Inc. Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 28, 2009 Opportunity Dairy Denver District Office Illegal Drug Residue N/A *
May 27, 2009 R P Gomes, Inc. New Jersey District Office Seafood HACCP/Adulterated N/A *
May 27, 2009 Union Springs Pharmaceuticals Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 26, 2009 Guilin Hospital of Sino-western Medicine Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 22, 2009 Crystal Care International Inc Florida District Office CGMP/QSR/Medical Device/Adulterated N/A *
May 22, 2009 Nozin LLC Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 22, 2009 H & H Products Company Florida District Office Juice HACCP/Adulterated N/A *
May 21, 2009 Chi Machine International Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
May 21, 2009 Sitek Research Laboratories Center for Drug Evaluation and Research GLP/Bioresearch Monitoring Program N/A *
May 21, 2009 Southern Foods Group, LLC Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
May 20, 2009 Richard E. Ringel, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
May 20, 2009 Rocky Mountain Environmental Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
May 20, 2009 Feins, Neil R., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
May 20, 2009 Water and Power Technologies, Inc Dallas District Office CGMP/QSR/Adulterated N/A *
May 20, 2009 Xttrium Laboratories, Inc. Chicago District Office Drug Manufacturing Operations/CGMP deviations 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 Perelandra, LTD Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *



 

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ICECI Warning Letters

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