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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

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

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
09/09/2011 Dr Foster'S Essentials [ARCHIVED] Los Angeles District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
09/09/2011 Sichuan Pharmaceutical Co., Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
09/09/2011 Nutri-West, Incorporated [ARCHIVED] Denver District Office CGMP For Manufacturing, Packaging, Labeling, or Holding for Dietary Supplements/Adulterated 01/24/2013
09/09/2011 United Contact Lens [ARCHIVED] Seattle District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 02/22/2012
09/08/2011 RX Air Industries LLC. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
09/08/2011 Paramount Muffins, LLC [ARCHIVED] New Jersey District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 08/29/2012
09/08/2011 Postres de Aqui, Inc. [ARCHIVED] San Juan District Office Food Labeling/Adulterated/Misbranded Not Issued *
09/07/2011 Covenant Healthcare [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
09/07/2011 Chronicity Inc. [ARCHIVED] Dallas District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
09/06/2011 Moor Instruments Ltd [ARCHIVED] Center for Devices and Radiological Health Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Not Issued *
09/06/2011 24/7 Seafood Distributor Corp. [ARCHIVED] Florida District Office CGMP Regulation For Food/Adulterated Not Issued *
09/06/2011 High Quality Organics, Inc. [ARCHIVED] San Francisco District Office Interstate Commerce/Food/Adulterated 06/27/2012
09/06/2011 Advantage Foods, LLC [ARCHIVED] Florida District Office CGMP Regulation For Food/Adulterated Not Issued *
09/01/2011 Deibel Laboratories of Illinois, Inc. [ARCHIVED] Chicago District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated 11/12/2013
09/01/2011 Lonza Biologics, Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
08/31/2011 EPI, LLC. [ARCHIVED] Chicago District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
08/31/2011 Luitpold Pharmaceuticals, Inc. [ARCHIVED] New York District Office CGMP for Finished Pharmaceuticals/Adulterated 08/21/2015
08/31/2011 The Smokehouse, LLC. d/b/a La Maree Smokehouse [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/30/2011 Willharvdoit Corporation [ARCHIVED] Minneapolis District Office CGMP Regulation For Food/Adulterated 03/27/2012
08/30/2011 Forsman Farms, Inc [ARCHIVED] Minneapolis District Office PHS Act/Violation 09/13/2012
08/29/2011 Dakota Pure Water, Inc. [ARCHIVED] Minneapolis District Office CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated 06/05/2013
08/29/2011 Beach Products, Inc. [ARCHIVED] Atlanta District Office CGMP Regulation for Finished Pharmaceuticals/Adulterated Not Issued *
08/29/2011 CHG Hospital Beds, Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 11/02/2011
08/29/2011 South Texas Innovative Medicine [ARCHIVED] Center for Devices and Radiological Health Sponsor-Investigator Not Issued *
08/26/2011 Micro Distributing II, Ltd. [ARCHIVED] Dallas District Office Medical Device Reporting/Misbranded Not Issued *
08/26/2011 Santa Fe Natural Tobacco Company [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 10/14/2011
08/26/2011 Caton, John Jr., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
08/26/2011 Accuron Technologies (Dornier Medtech Systems GmbH ) [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 07/05/2012
08/25/2011 Edelweiss Farms, Inc. [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
08/25/2011 Noven Pharmaceuticals, Inc. [ARCHIVED] Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated 10/02/2012
08/25/2011 Blue Jay Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue Not Issued *
08/25/2011 Galloway Technologies, L.C. [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/24/2011 Sam-Go Products [ARCHIVED] Dallas District Office CGMP/QSR/Medical Device Reporting/Adulterated Not Issued *
08/23/2011 ThyssenKrupp Access Corp. [ARCHIVED] Kansas City District Office Premarket Approval/Misbranded/Adulterated Not Issued *
08/22/2011 Brazilian Blowout [ARCHIVED] Center for Food Safety and Applied Nutrition Cosmetics/Adulterated/Misbranded Not Issued *
08/22/2011 Pharmacist's Ultimate Health Corp. [ARCHIVED] Minneapolis District Office Labeling Claims Not Issued *
08/19/2011 For Earth, Inc. [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims Not Issued *
08/19/2011 Windy Ridge Dairy [ARCHIVED] Detroit District Office Illegal Drug Residue Not Issued *
08/18/2011 Uriel Pharmacy, Inc [ARCHIVED] Minneapolis District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated 06/07/2013
08/18/2011 Davis Farm [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
08/18/2011 King Juice Company., Inc. [ARCHIVED] Minneapolis District Office Juice/HACCP/Adulterated/Insanitary Conditions 04/19/2013
08/18/2011 Leland Bruce Shaw [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
08/18/2011 River Valley Ranch Ltd [ARCHIVED] Minneapolis District Office Acidified Foods/Acid Canned Food Regulation/Adulterated 10/14/2016
08/18/2011 Miramar Cosmetics, Inc. [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
08/18/2011 Sugar Plum Foods [ARCHIVED] New Orleans District Office Acidified Foods/Acid Canned Food Regulation/Adulterated Not Issued *
08/17/2011 www.buycheapcigs.net [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products 09/30/2011
08/17/2011 www.cigs4u.net [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products 09/29/2011
08/16/2011 Muddypaws Cheesecake Co. [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded 04/19/2013
08/16/2011 Best of Texas, Inc. [ARCHIVED] Dallas District Office Acidified Foods/Adulterated Not Issued *
08/15/2011 GYN Disposables, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *

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