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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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

Posted on September 27, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
August 19, 2011 For Earth, Inc. Florida District Office New Drug/Labeling/False & Misleading Claims Not Issued *
August 19, 2011 Windy Ridge Dairy Detroit District Office Illegal Drug Residue Not Issued *
August 18, 2011 King Juice Company., Inc. Minneapolis District Office Juice/HACCP/Adulterated/Insanitary Conditions April 19, 2013
August 18, 2011 Sugar Plum Foods New Orleans District Office Acidified Foods/Acid Canned Food Regulation/Adulterated Not Issued *
August 18, 2011 Leland Bruce Shaw New York District Office Illegal Drug Residue Not Issued *
August 18, 2011 Miramar Cosmetics, Inc. Florida District Office CGMP for Finished Pharmaceuticals/Misbranded/Adu lterated Not Issued *
August 18, 2011 River Valley Ranch Ltd Minneapolis District Office Acidified Foods/Acid Canned Food Regulation/Adulterated Not Issued *
August 18, 2011 Davis Farm New York District Office Illegal Drug Residue Not Issued *
August 18, 2011 Uriel Pharmacy, Inc Minneapolis District Office CGMP for Finished Pharmaceuticals/Misbranded/Adu lterated Not Issued *
August 17, 2011 www.buycheapcigs.net Center for Tobacco Products Modified Risk Tobacco Products September 30, 2011
August 17, 2011 www.cigs4u.net Center for Tobacco Products Modified Risk Tobacco Products September 29, 2011
August 16, 2011 Muddypaws Cheesecake Co. Minneapolis District Office Food Labeling/Misbranded April 19, 2013
August 16, 2011 Best of Texas, Inc. Dallas District Office Acidified Foods/Adulterated Not Issued *
August 15, 2011 SCT Corporation Baltimore District Office Labeling/Misbranded Not Issued *
August 15, 2011 GYN Disposables, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 15, 2011 ProSun International, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 15, 2011 TCA Cellular Therapy, LLC Center for Biologics Evaluation and Research Bioresearch Monitoring Program/IRB Not Issued *
August 12, 2011 GD Designs, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 12, 2011 Askar Solutions, Ltd. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 30, 2011
August 12, 2011 Cohen, Yale M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *


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