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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 May 03, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 28, 2011 Derma Remedies Center for Drug Evaluation and Research New Drug/Misbranded Not Issued *
April 28, 2011 Viruxo.com Center for Food Safety and Applied Nutrition New Drug/Misbranded Not Issued *
April 28, 2011 Flor Nutraceuticals, LLC Dallas District Office New Drug/Misbranded Not Issued *
April 28, 2011 Generic Medical Devices, Inc. Seattle District Office Premarket Approval/Misbranded/Adulterated July 29, 2011
April 28, 2011 Captain's Fine Foods, LLC Florida District Office CGMP for Foods/Seafood HACCP/Adulterated September 13, 2011
April 28, 2011 Immuneglory.com San Francisco District Office New Drug/Misbranded Not Issued *
April 28, 2011 Lesa Sverid New England District Office Drug Products/Therapeutic Claims Not Issued *
April 28, 2011 Great Oriental Food Products Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated June 21, 2011
April 28, 2011 Medavir Medical Advances, Inc. Florida District Office New Drug/Misbranded Not Issued *
April 28, 2011 Chlamydia-clinic.com San Francisco District Office Drug Products/Therapeutic Claims Not Issued *
April 27, 2011 Intelli Health Products, LLC Florida District Office Promotional Claims/New Drug/Misbranded Not Issued *
April 26, 2011 Dangjin Food Inc. Center for Food Safety and Applied Nutrition Seafood HACCP Not Issued *
April 26, 2011 La Placita Botanas Mexicanus, Inc. Los Angeles District Office CGMP/Misbranded Not Issued *
April 26, 2011 Guangxi Jisheng Foods Inc Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated June 30, 2011
April 26, 2011 Golden State Medical Supply, Inc. Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated April 19, 2012
April 25, 2011 Cephazone Pharma LLC Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated June 21, 2012
April 25, 2011 Natural Path / Silver Wings, LLC New Orleans District Office CGMP/Unapproved New Drug/Dietary Supplement/Adulterated/Misbranded Not Issued *
April 22, 2011 Healthcare Authority of the City of Demopolis New Orleans District Office Mammography Quality Standards Act Not Issued *
April 22, 2011 ZOLL Medical Corporation New England District Office CGMP for Medical Devices/QS/Adulterated April 23, 2012
April 22, 2011 Solar Wide Industrial Ltd Center for Devices and Radiological Health CGMP/Quality System, Promotion and Advertsing, and Device Registration Not Issued *


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