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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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
December 01, 2009 www.secretsofbetterhealth.com dba My Cosmetic Company Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
December 01, 2009 Tetracore, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated August 23, 2010
November 30, 2009 www.bestswinefluvaccine.com Center for Biologics Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
November 30, 2009 Chaur Fong Inc. dba 888 Food Company Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 30, 2009 Aregenius Worldwide LLC Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
November 30, 2009 Aluwe, LLC Minneapolis District Office Unapproved New Drug/Misbranded Not Issued *
November 30, 2009 Hyde Park Holistic Center Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
November 27, 2009 GDMI, Inc Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
November 27, 2009 CFM dba Your Deli Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated Not Issued *
November 27, 2009 ICON Clinical Research, Inc. Center for Drug Evaluation and Research Sponsor-Applicant-Monitor-Clinical Research Organization Not Issued *
November 24, 2009 U.F. Union International Food Company San Francisco District Office CGMP/Deviations/Adulterated December 16, 2010
November 24, 2009 Buettner, Craig M., MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 24, 2009 Gazda, Thomas M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 23, 2009 Quesnel Livestock New England District Office Illegal Drug Residue Not Issued *
November 20, 2009 Wellspring International, Inc. Minneapolis District Office Unapproved New Drug Not Issued *
November 20, 2009 Pan American Laboratories, LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
November 20, 2009 Microsulis Medical Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 20, 2009 Centra Health Inc Irb Center for Devices and Radiological Health Investigational Device Exemptions Not Issued *
November 20, 2009 Huaiyin Medical Instruments Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 19, 2009 Mason Brothers Co Minneapolis District Office CGMP for Foods/Seafood HACCP/Adulterated July 13, 2011



 

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