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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
August 15, 2011 ProSun International, LLC [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 15, 2011 SCT Corporation [ARCHIVED] Baltimore District Office Labeling/Misbranded March 09, 2012
August 15, 2011 TCA Cellular Therapy, LLC Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
August 12, 2011 GD Designs, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
August 12, 2011 Askar Solutions, Ltd. [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded September 30, 2011
August 12, 2011 Cohen, Yale M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
August 11, 2011 Shenberg Dental, dba Therozone [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 11, 2011 Michael P. Ferry Inc. [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
August 11, 2011 Dockside Fish Market [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 14, 2016
August 10, 2011 Sampson, Clint [ARCHIVED] Minneapolis District Office Illegal Drug Residue June 05, 2013
August 10, 2011 Farm and Wild Fresh Paradise Gourmet Foods [ARCHIVED] Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
August 10, 2011 H & L Jerch Sales, Inc. d/b/a Bell Lifestyle Products Inc [ARCHIVED] Detroit District Office New Drug/Labeling/Misbranded June 07, 2013
August 10, 2011 Hide A Way Dairy [ARCHIVED] Denver District Office Illegal Drug Residue Not Issued *
August 09, 2011 Beckman Coulter, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated August 15, 2012
August 09, 2011 American Quality Manufacturing, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded January 31, 2012
August 09, 2011 Philadelphia International Airport [ARCHIVED] Philadelphia District Office Interstate Conveyance Sanitation Regulations/Provisional October 04, 2011
August 08, 2011 Kimriv Restaurant Group, LLC. (DBA) Royal Gourmet Foods [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 08, 2011 The North West Company International, Inc. [ARCHIVED] Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions April 16, 2012
August 08, 2011 Porky Products Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated February 21, 2012
August 08, 2011 The Best Chocolate In Town [ARCHIVED] Detroit District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions March 21, 2012
August 08, 2011 Sivertson Fisheries Inc. dba Lake Superior Fish Company [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated June 27, 2012
August 05, 2011 Nanjing Maohai Biotech Co. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 05, 2011 Zhejiang Casing Animal By-Products Co. Ltd [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
August 05, 2011 Lisbon Centre Farms [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
August 05, 2011 Vorsteveld Farm, LLP [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
August 05, 2011 Superstat Corp [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 04, 2011 Creation's Garden Natural Products, Inc. [ARCHIVED] Los Angeles District Office New Drug/Misbranded Not Issued *
August 04, 2011 Patient Transfer Systems, Inc [ARCHIVED] Philadelphia District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated January 30, 2012
August 02, 2011 Sorin Group Deutschland GmbH [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
August 02, 2011 Deshaies' Associates, Inc., d/b/a Deshaies' Lobster Salad [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 02, 2011 Hoya Surgical Optics, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
August 01, 2011 Jin's Seafood Enterprise Inc., dba Choi's Fish Market [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated Not Issued *
August 01, 2011 Hickory Smokehouse Miami, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 01, 2011 Double M Jerseys [ARCHIVED] San Francisco District Office Illegal Drug Residue Not Issued *
August 01, 2011 Pacific Cheese Company, Inc. [ARCHIVED] San Francisco District Office Food/Adulterated August 20, 2012
July 29, 2011 Pharmaceutical Innovations, Inc. [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 29, 2011 www.online-smoke.com [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
July 28, 2011 Timothy R. Nelson [ARCHIVED] Kansas City District Office Illegal Drug Residue November 07, 2012
July 28, 2011 Pine Groves Farm Ltd. [ARCHIVED] Kansas City District Office Illegal Drug Residue November 07, 2012
July 28, 2011 Merex Inc [ARCHIVED] Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
July 28, 2011 Uttecht, Kenneth [ARCHIVED] Minneapolis District Office Illegal Drug Residue October 12, 2011
July 28, 2011 HBB, LLC dba Baked World [ARCHIVED] Center for Food Safety and Applied Nutrition Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
July 27, 2011 Bionet Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 27, 2011 Gulf Medical Fiberoptics, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 27, 2011 La Villa Tortilleria, Inc. [ARCHIVED] New Orleans District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
July 27, 2011 Diana Fruit Company Incorporated [ARCHIVED] San Francisco District Office Acidified Foods/Acid Canned Food Regulation/Adulterated October 11, 2012
July 26, 2011 Edenic Soy & Tofu, Inc [ARCHIVED] Chicago District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
July 26, 2011 Laboratorios B. Braun S.A [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated and Medical Device Reporting/Misbranded Not Issued *
July 26, 2011 D & D Catering, Inc. [ARCHIVED] Florida District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions March 16, 2012
July 26, 2011 Essex Institutional Review Board, Inc [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *

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