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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
08/15/2011 ProSun International, LLC [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/15/2011 SCT Corporation [ARCHIVED] Baltimore District Office Labeling/Misbranded 03/09/2012
08/15/2011 TCA Cellular Therapy, LLC Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
08/12/2011 GD Designs, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/12/2011 Askar Solutions, Ltd. [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/30/2011
08/12/2011 Cohen, Yale M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
08/11/2011 Shenberg Dental, dba Therozone [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/11/2011 Michael P. Ferry Inc. [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
08/11/2011 Dockside Fish Market [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/14/2016
08/10/2011 Sampson, Clint [ARCHIVED] Minneapolis District Office Illegal Drug Residue 06/05/2013
08/10/2011 Farm and Wild Fresh Paradise Gourmet Foods [ARCHIVED] Seattle District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
08/10/2011 H & L Jerch Sales, Inc. d/b/a Bell Lifestyle Products Inc [ARCHIVED] Detroit District Office New Drug/Labeling/Misbranded 06/07/2013
08/10/2011 Hide A Way Dairy [ARCHIVED] Denver District Office Illegal Drug Residue Not Issued *
08/09/2011 Beckman Coulter, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated 08/15/2012
08/09/2011 American Quality Manufacturing, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 01/31/2012
08/09/2011 Philadelphia International Airport [ARCHIVED] Philadelphia District Office Interstate Conveyance Sanitation Regulations/Provisional 10/04/2011
08/08/2011 Kimriv Restaurant Group, LLC. (DBA) Royal Gourmet Foods [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/08/2011 The North West Company International, Inc. [ARCHIVED] Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions 04/16/2012
08/08/2011 Porky Products Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Adulterated 02/21/2012
08/08/2011 The Best Chocolate In Town [ARCHIVED] Detroit District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 03/21/2012
08/08/2011 Sivertson Fisheries Inc. dba Lake Superior Fish Company [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated 06/27/2012
08/05/2011 Nanjing Maohai Biotech Co. [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/05/2011 Zhejiang Casing Animal By-Products Co. Ltd [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
08/05/2011 Lisbon Centre Farms [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
08/05/2011 Vorsteveld Farm, LLP [ARCHIVED] New England District Office Illegal Drug Residue Not Issued *
08/05/2011 Superstat Corp [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/04/2011 Creation's Garden Natural Products, Inc. [ARCHIVED] Los Angeles District Office New Drug/Misbranded Not Issued *
08/04/2011 Patient Transfer Systems, Inc [ARCHIVED] Philadelphia District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 01/30/2012
08/02/2011 Sorin Group Deutschland GmbH [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
08/02/2011 Deshaies' Associates, Inc., d/b/a Deshaies' Lobster Salad [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/02/2011 Hoya Surgical Optics, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
08/01/2011 Jin's Seafood Enterprise Inc., dba Choi's Fish Market [ARCHIVED] San Francisco District Office Seafood HACCP/Adulterated Not Issued *
08/01/2011 Pacific Cheese Company, Inc. [ARCHIVED] San Francisco District Office Food/Adulterated 08/20/2012
08/01/2011 Hickory Smokehouse Miami, Inc. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
08/01/2011 Double M Jerseys [ARCHIVED] San Francisco District Office Illegal Drug Residue Not Issued *
07/29/2011 Pharmaceutical Innovations, Inc. [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/29/2011 www.online-smoke.com [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
07/28/2011 Timothy R. Nelson [ARCHIVED] Kansas City District Office Illegal Drug Residue 11/07/2012
07/28/2011 Pine Groves Farm Ltd. [ARCHIVED] Kansas City District Office Illegal Drug Residue 11/07/2012
07/28/2011 Merex Inc [ARCHIVED] Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
07/28/2011 Uttecht, Kenneth [ARCHIVED] Minneapolis District Office Illegal Drug Residue 10/12/2011
07/28/2011 HBB, LLC dba Baked World [ARCHIVED] Center for Food Safety and Applied Nutrition Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
07/27/2011 Bionet Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
07/27/2011 Gulf Medical Fiberoptics, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
07/27/2011 La Villa Tortilleria, Inc. [ARCHIVED] New Orleans District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
07/27/2011 Diana Fruit Company Incorporated [ARCHIVED] San Francisco District Office Acidified Foods/Acid Canned Food Regulation/Adulterated 10/11/2012
07/26/2011 Edenic Soy & Tofu, Inc [ARCHIVED] Chicago District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
07/26/2011 Laboratorios B. Braun S.A [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated and Medical Device Reporting/Misbranded Not Issued *
07/26/2011 D & D Catering, Inc. [ARCHIVED] Florida District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 03/16/2012
07/26/2011 Essex Institutional Review Board, Inc [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *

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