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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 November 29, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 28, 2011 Hcg-miracleweightloss.com Seattle District Office Homeopathic HCG Initiative April 16, 2012
November 28, 2011 Natural Medical Supply, LLC DBA HCG Complete Diet Denver District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 Theoriginalhcgdrops.com New York District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 HCG Platinum, LLC Denver District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 Nutri Fusion Systems, Inc Denver District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 John Bootsma Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
November 25, 2011 Robert Bugatto Enterprises, Inc., dba The Tides Wharf San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
November 25, 2011 E and M Bakery, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 24, 2011 Precision Formulations, LP Dallas District Office CGMP/Dietary Supplement/Adulterated Not Issued *
November 23, 2011 Hill's Pet Nutrition Inc Kansas City District Office Labeling/Unapproved New Animal Drug/Adulterated Not Issued *
November 23, 2011 Big D Ranch, Inc. Seattle District Office Adulterated Food Not Issued *
November 23, 2011 Quinault Tribal Enterprise dba Quinault Pride Seattle District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
November 22, 2011 Bartush-Schnitzius Foods Co Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 22, 2011 CocoKefir LLC Minneapolis District Office Promotional Claims False & Misleading/New Drugs June 03, 2013
November 22, 2011 NanoLiposomal Nutritionals Los Angeles District Office Unapproved Drugs/Misbranded Not Issued *
November 22, 2011 H. R. Beal & Sons New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 22, 2011 H & A Mui Enterprises Inc. Center for Devices and Radiological Health Adultered Device/Misbranding/Quality System   Not Issued *
November 21, 2011 Tuller, Betty Ph.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 21, 2011 Dutch Valley Food Development Inc. Philadelphia District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions April 05, 2012
November 18, 2011 Osmed GmbH Center for Devices and Radiological Health Device Adulterated/Misbranded Not Issued *


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