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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005

Warning Letters issued in 2010

 

* 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
12/30/2010 Dr. Christopher's [ARCHIVED] Denver District Office Drug Products/Therapeutic Claims Not Issued *
12/28/2010 McGuff Pharmaceuticals Inc. [ARCHIVED] Los Angeles District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated 04/25/2012
12/28/2010 Novacare, LLC [ARCHIVED] Denver District Office Unapproved New Drugs/Misbranded Dietary Supplements Not Issued *
12/28/2010 Pacific Exchange Distributors, Llc [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
12/23/2010 Syneron, Inc [ARCHIVED] Los Angeles District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)/Misbranded 04/03/2012
12/22/2010 Abon Biopharm (Hangzhou) Co., Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 10/16/2012
12/22/2010 Vistar Corporation [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
12/22/2010 Heritage Labs International LLC [ARCHIVED] Kansas City District Office Premarket Approval/Adulterated/Misbranded 07/14/2011
12/22/2010 Aqueduct Medical, Inc. [ARCHIVED] San Francisco District Office Lacks Premarket Approval Application/Adulterated/Misbranded Not Issued *
12/22/2010 Access Bio, Inc. [ARCHIVED] New Jersey District Office Lacks Premarket Approval/Adulterated 01/09/2017
12/22/2010 Bauer & Hasselbarth Gmbh [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 01/11/2012
12/21/2010 Natural Options Corp [ARCHIVED] Florida District Office New Drug/Adulterated/Misbranded Not Issued *
12/21/2010 Klinge Chemicals Limited [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated 10/22/2012
12/21/2010 Smith & Nephew Orthopaedics Gmbh [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 06/20/2013
12/21/2010 Tico's Mexican Foods, inc. [ARCHIVED] Denver District Office Seafood HACCP/Insanitary Conditions/Adulterated Not Issued *
12/21/2010 Natural Zing, LLC [ARCHIVED] Baltimore District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *
12/21/2010 CIBA Vision Puerto Rico, Inc. [ARCHIVED] San Juan District Office CGMP/QSR/Medical Devices/Adulterated 09/14/2011
12/20/2010 Peregrine Surgical Ltd [ARCHIVED] Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/20/2010 Wild Thymes Farm, Inc. [ARCHIVED] New York District Office Acidified Foods/Adulterated Not Issued *
12/16/2010 Synbiotics Ltd [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated 08/26/2016
12/16/2010 Karlsburger Foods, Inc. [ARCHIVED] Minneapolis District Office CGMP for Foods/Seafood HACCP/Adulterated/Misbranded 10/31/2011
12/16/2010 Mega Sun Inc [ARCHIVED] Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
12/16/2010 Verichem Laboratories, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/15/2010 Innovative Medical Manufacturing Co [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
12/15/2010 Invacare Corporation [ARCHIVED] Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded Not Issued *
12/15/2010 NOC Management Co. Inc. [ARCHIVED] Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/15/2011
12/14/2010 Cherokee Brands, LLC [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 02/10/2011
12/14/2010 E.A. Beck & Co. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
12/13/2010 Ray's Seafood Market, Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/17/2011
12/10/2010 Naturally For Her [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
12/10/2010 Ian's Natural Foods, Inc [ARCHIVED] New England District Office CGMP Regulation For Food/Adulterated Not Issued *
12/10/2010 Macco Organiques [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated 03/10/2014
12/09/2010 Yuki Gosei Kogyo Co., Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated 11/23/2012
12/09/2010 American Seafood Company Inc [ARCHIVED] New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
12/09/2010 New Life Alternatives [ARCHIVED] New Orleans District Office Dietary Supplements Not Issued *
12/07/2010 Profit & Loss Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue Not Issued *
12/07/2010 VBM Medizintechnik GmbH [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
12/07/2010 Newman's Fish Markets, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
12/07/2010 Copper River Seafoods, Inc. [ARCHIVED] Seattle District Office CGMP for Foods/Seafood HACCP/Adulterated &Low Acid Canned Food Regulation Not Issued *
12/07/2010 BioCheck Inc [ARCHIVED] San Francisco District Office Premarket Approval/Adulterated/Misbranded 02/16/2011
12/06/2010 Lady-Comp USA [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
12/06/2010 Valley Electronics GmbH [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
12/06/2010 Natural Methods, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
12/06/2010 GAR Laboratories Inc [ARCHIVED] Los Angeles District Office CGMP/Finished Products/Adulterated Not Issued *
12/06/2010 New Wha Ming Trading of MN, Inc [ARCHIVED] Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated 07/08/2011
12/03/2010 Iso-Tex Diagnostics, Inc [ARCHIVED] Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
12/03/2010 Hain Celestial Group [ARCHIVED] Denver District Office CGMP For Manufacturing, Packing, or Holding Human Food 12/06/2011
12/02/2010 PCI Synthesis [ARCHIVED] New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated 09/29/2011
12/02/2010 United Taiwan Corp. - Chao Zhou Plant [ARCHIVED] Center for Food Safety and Applied Nutrition CGMP for Deviations/Adulterated 05/19/2011
12/02/2010 Prolatis [ARCHIVED] Denver District Office Dietary Supplement/Adulterated Not Issued *

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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