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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
03/28/2011 Philips Medical Systems [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/28/2011 Lena's Lefse, Inc. [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded 01/31/2012
03/28/2011 Drake Dairy, Inc. [ARCHIVED] Minneapolis District Office Illegal Drug Residue 06/05/2013
03/28/2011 Able Cold Storage & Trucking [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated 12/19/2011
03/28/2011 Saw Palmetto Harvesting Co. [ARCHIVED] Florida District Office New Drug/Misbranded Not Issued *
03/25/2011 Van Es Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
03/25/2011 True World Food Boston, LLC [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 08/30/2011
03/25/2011 Day Boat Seafood LLC [ARCHIVED] Florida District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
03/25/2011 Soluble Products Co., LP [ARCHIVED] New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
03/24/2011 American Association of Acupuncture and Bio-Energetic Medicine [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
03/24/2011 Express Diagnostics International, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 10/14/2011
03/24/2011 Valor Medical Inc [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
03/24/2011 Jonathan's Sprouts Inc. [ARCHIVED] New England District Office Labeling/New Drug/Misbranded 06/22/2011
03/24/2011 Air Wisconsin Airlines Corporation [ARCHIVED] Philadelphia District Office Interstate Conveyance Sanitation Regulations 10/04/2011
03/23/2011 BC Group International, Inc. [ARCHIVED] Kansas City District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 01/06/2012
03/23/2011 Jonlly Fruits, Inc. [ARCHIVED] San Juan District Office CGMP Regulation for Foods/Juice HACCP/Adulterated Not Issued *
03/22/2011 Zimmerman, Mark S. [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
03/22/2011 DiaPharma Group Inc [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/22/2011 Dixie Mills, LLC [ARCHIVED] Atlanta District Office CGMP Regulations for Food/Adulterated Not Issued *
03/22/2011 Meditherm Inc. [ARCHIVED] Center for Devices and Radiological Health False & Misleading Claims/Misbranded. Not Issued *
03/21/2011 Zaiac, Martin N. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
03/21/2011 Horowitz, Jeffrey M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
03/18/2011 Caridian BCT Inc. [ARCHIVED] Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 11/21/2011
03/18/2011 Pt. Indomaguro Tunas Unggul [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/18/2011 Horizon Acres Cincinnati District Office Illegal Drug Residue Not Issued *
03/18/2011 Non-Invasive Monitoring Systems, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated 06/24/2013
03/17/2011 Dakota Laboratories, Llc [ARCHIVED] Minneapolis District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
03/16/2011 Airline Seafood, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated 09/06/2013
03/16/2011 Eidosmed [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/14/2011 Galati Cheese Company Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
03/14/2011 R82 A/S [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/14/2011 Griffin, John M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
03/14/2011 Health Robotics Srl [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 05/17/2013
03/11/2011 Shemshad Food Products, Inc [ARCHIVED] Los Angeles District Office CGMP Food Labeling/False & Misleading/Claims Misbranded & Acidified Foods/Adulterated Not Issued *
03/11/2011 Cajun Crab, LLC [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated 05/24/2012
03/09/2011 BioSculptor Corporation [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/09/2011 PT. Tuna Permata Rezeki [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/08/2011 Rebuilder Medical, Inc. [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Devices/Adulterated 08/10/2011
03/08/2011 Wimberger's Old World Bakery [ARCHIVED] Denver District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
03/04/2011 Goetze's Candy Company Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
03/04/2011 AZ Instrument (Shen Zhen) Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/04/2011 AZ Instrument (Shen Zhen) Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 01/05/2015
03/04/2011 Azevedo and Sons Dairy, Inc. Seattle District Office Illegal Drug Residue Not Issued *
03/04/2011 Amting Dairy Farm [ARCHIVED] Detroit District Office Illegal Drug Residue Not Issued *
03/03/2011 2035, Inc. [ARCHIVED] Minneapolis District Office Premarket Approval/Misbranded/Adulterate d Not Issued *
03/03/2011 Eagle Diagnostics, Inc [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/03/2011 Eagle Diagnostics, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/03/2011 Queseria Chipilo, Inc. [ARCHIVED] New Jersey District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions 11/08/2011
03/02/2011 Four Sea's Inc. [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/22/2011
03/02/2011 Gaspari Nutrition, Inc. [ARCHIVED] New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 08/16/2011

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