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

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