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