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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 28, 2011 Pacific Naturals Los Angeles District Office New Drug/Misbranded Not Issued *
April 28, 2011 Polydna New York District Office Drug Products/Therapeutic Claims Not Issued *
April 28, 2011 Lesa Sverid New England District Office Drug Products/Therapeutic Claims Not Issued *
April 28, 2011 Derma Remedies Center for Drug Evaluation and Research 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 Immuneglory.com San Francisco District Office New Drug/Misbranded Not Issued *
April 28, 2011 Everclr3 Seattle District Office Drug Products/Therapeutic Claims Not Issued *
April 28, 2011 Chlamydia-clinic.com San Francisco District Office Drug Products/Therapeutic Claims Not Issued *
April 28, 2011 Medavir Medical Advances, Inc. Florida District Office New Drug/Misbranded Not Issued *
April 28, 2011 Premier Micronutrient Corporation New Orleans District Office Labeling Drug Claims Not Issued *
April 28, 2011 Captain's Fine Foods, LLC Florida District Office CGMP for Foods/Seafood HACCP/Adulterated September 13, 2011
April 28, 2011 Flor Nutraceuticals, LLC Dallas District Office 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 Great Oriental Food Products Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated June 21, 2011
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 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 26, 2011 La Placita Botanas Mexicanus, Inc. Los Angeles District Office CGMP/Misbranded Not Issued *
April 25, 2011 Cephazone Pharma LLC Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated June 21, 2012



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