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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 09, 2011 Light-Tech, Inc. [ARCHIVED] Florida District Office Medical Device Reporting/Misbranded Not Issued *
December 09, 2011 Quasar Bio-Tech, Inc. dba Silver Bay LLC [ARCHIVED] Florida District Office Premarket Approval/Misbranded/Adulterated Not Issued *
December 09, 2011 Fuller Family Dairy, LLC [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
December 09, 2011 Beverly Hills Surgery Center, LLC [ARCHIVED] Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 09, 2011 San Diego Ambulatory Surgery Center, LLC [ARCHIVED] Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 09, 2011 Valencia Ambulatory Surgery Center, LLC [ARCHIVED] Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 09, 2011 Palmdale Ambulatory Surgery Center [ARCHIVED] Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
December 08, 2011 DePuy Orthopaedics, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated September 27, 2012
December 08, 2011 Revolt Distribution Inc. [ARCHIVED] Atlanta District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
December 08, 2011 Gabrimar Export Fish, S.A. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
December 08, 2011 GF Health Products, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated March 26, 2013
December 07, 2011 Beck's Smokery [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 07, 2011 Sushi Avenue, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 31, 2012
December 06, 2011 FFE Transportation Services, Inc [ARCHIVED] Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 06, 2011 Gresco Products, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated January 30, 2013
December 06, 2011 Med-Chem Labs [ARCHIVED] Detroit District Office Promotional Claims False & Misleading/New Drugs Not Issued *
December 06, 2011 Crown O'Maine Organic Cooperative [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 29, 2013
December 06, 2011 Italian Rose Garlic Products, Inc [ARCHIVED] Florida District Office Acidified Foods/Acid Canned Food Regulation/Adulterated October 26, 2012
December 05, 2011 Frog Island Seafood Inc [ARCHIVED] Atlanta District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 05, 2011 Ion Labs Inc. [ARCHIVED] Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
December 05, 2011 CooperVision, Inc. [ARCHIVED] New York District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated July 05, 2012
December 01, 2011 Precision Herbs, LLC [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
December 01, 2011 DreamLife, LLC [ARCHIVED] New Orleans District Office CGMP/Dietary Supplement/Adulterated Not Issued *
December 01, 2011 United States Cold Storage, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 30, 2011 Middlebury Large Animal Clinic [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
November 30, 2011 Antonio Resendes [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
November 29, 2011 Silver Moon Springs LLC [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded Not Issued *
November 29, 2011 Merits Health Products Co., Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated January 30, 2013
November 28, 2011 Creative Bioscience, LLC Center for Drug Evaluation and Research Homeopathic HCG Initiative Not Issued *
November 28, 2011 Sunnyside Poultry Farms [ARCHIVED] Baltimore District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
November 28, 2011 Hcg-miracleweightloss.com [ARCHIVED] Seattle District Office Homeopathic HCG Initiative April 16, 2012
November 28, 2011 Nutri Fusion Systems, Inc [ARCHIVED] Denver District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 Theoriginalhcgdrops.com [ARCHIVED] New York District Office Homeopathic HCG Initiative September 17, 2014
November 28, 2011 HCG Diet Direct, LLC [ARCHIVED] Los Angeles District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 HCG Platinum, LLC [ARCHIVED] Denver District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 Natural Medical Supply, LLC DBA HCG Complete Diet [ARCHIVED] Denver District Office Homeopathic HCG Initiative Not Issued *
November 28, 2011 John Bootsma Dairy [ARCHIVED] Los Angeles District Office Illegal Drug Residue Not Issued *
November 25, 2011 Ottogi SF Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 25, 2011 Robert Bugatto Enterprises, Inc., dba The Tides Wharf [ARCHIVED] San Francisco District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
November 25, 2011 E and M Bakery, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 24, 2011 Precision Formulations, LP [ARCHIVED] Dallas District Office CGMP/Dietary Supplement/Adulterated Not Issued *
November 23, 2011 Hill's Pet Nutrition Inc [ARCHIVED] Kansas City District Office Labeling/Unapproved New Animal Drug/Adulterated Not Issued *
November 23, 2011 Quinault Tribal Enterprise dba Quinault Pride [ARCHIVED] Seattle District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
November 23, 2011 Big D Ranch, Inc. [ARCHIVED] Seattle District Office Adulterated Food Not Issued *
November 22, 2011 Bartush-Schnitzius Foods Co [ARCHIVED] Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 22, 2011 H & A Mui Enterprises Inc. [ARCHIVED] Center for Devices and Radiological Health Adultered Device/Misbranding/Quality System   December 14, 2015
November 22, 2011 CocoKefir LLC [ARCHIVED] Minneapolis District Office Promotional Claims False & Misleading/New Drugs June 03, 2013
November 22, 2011 NanoLiposomal Nutritionals [ARCHIVED] Los Angeles District Office Unapproved Drugs/Misbranded Not Issued *
November 22, 2011 H. R. Beal & Sons [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions July 16, 2014
November 21, 2011 Tuller, Betty Ph.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *

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