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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
03/01/2011 StarKist Company [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated 07/26/2013
03/01/2011 Willing's Group, Inc. [ARCHIVED] New Jersey District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated 10/27/2011
03/01/2011 Jaba Labs [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded 03/30/2011
02/28/2011 Evershing International Trading Inc. [ARCHIVED] San Francisco District Office Seafood HACCP 08/02/2013
02/28/2011 Newport Lobster Company, Inc. [ARCHIVED] New England District Office Seafood HAACP/CGMP for Foods/Adulterated 10/24/2011
02/25/2011 Ohio Fresh Eggs LLC [ARCHIVED] Cincinnati District Office Unsanitary Conditions/Adulterated 12/06/2011
02/25/2011 Medela Inc [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated 04/14/2014
02/25/2011 Thurmond-Anderle, Margaret E. M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
02/25/2011 Cenova Innovation and Productions AB [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 08/13/2014
02/24/2011 InSight Dairy, LLC. New York District Office Illegal Drug Residue Not Issued *
02/24/2011 Gordon Food Service, Inc. [ARCHIVED] Detroit District Office Seafood HACCP/Adulterated 01/17/2012
02/23/2011 Sunrise Orchards Inc [ARCHIVED] Detroit District Office CGMP for Foods/Seafood HACCP/Adulterated 11/05/2013
02/23/2011 Sea Express Inc [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated 08/16/2011
02/22/2011 Nanotherapeutics, Inc [ARCHIVED] Florida District Office Device/Adulterated Not Issued *
02/18/2011 Tytan Medical, Corp. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
02/18/2011 Lifeway Foods, Inc. [ARCHIVED] Chicago District Office New Drug/Misbranded Not Issued *
02/18/2011 Simmons, John F, M. D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
02/18/2011 Nutrasilver.com [ARCHIVED] San Francisco District Office New Drug/Labeling/Misbranded Not Issued *
02/18/2011 Carioto Produce Inc [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
02/17/2011 Conservas y Congelados YAESTA, S.A. [ARCHIVED] Center for Food Safety and Applied Nutrition Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/17/2011 Millennium Bioceutics [ARCHIVED] Center for Food Safety and Applied Nutrition New Drugs/Dietary Supplements/Food Labeling/Misbranded Not Issued *
02/17/2011 Truman Sanner, DVM [ARCHIVED] Atlanta District Office Illegal Drug Residue Not Issued *
02/17/2011 Mancha, Vaughn H Jr, M. D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
02/17/2011 Rasi Laboratories, Inc. [ARCHIVED] New Jersey District Office CGMP/Dietary Supplement/Adulterated 08/16/2011
02/16/2011 Dobake Bakeries, Inc. [ARCHIVED] San Francisco District Office Foods/Misbranding Not Issued *
02/16/2011 Ratzan, Judith M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
02/16/2011 Mave Enterprises, Inc. [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions 08/09/2011
02/16/2011 Cordis LLC [ARCHIVED] San Juan District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 12/15/2011
02/16/2011 RHG & Company Inc., dba Vital Nutrients [ARCHIVED] New England District Office Dietary Supplement/Adulterated 02/13/2012
02/16/2011 Leong Kuba Sea Products, Inc [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/27/2011
02/15/2011 Jesse R. Petre Farm Philadelphia District Office Illegal Drug Residue Not Issued *
02/15/2011 Lloyd B. Zimmerman and Sons Philadelphia District Office Illegal Drug Residue Not Issued *
02/14/2011 Tyco Healthcare Canada [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/14/2011 Two Amigos Import & Export Inc [ARCHIVED] Florida District Office PHS Act/Violation 05/31/2012
02/14/2011 A-1 Eastern Homade Pickle Co., Inc. [ARCHIVED] Los Angeles District Office CGMP Regulation for Foods/Adulterated Not Issued *
02/11/2011 Anulex Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization Not Issued *
02/10/2011 Formatech Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
02/10/2011 Tabatchnick Fine Foods, Inc. [ARCHIVED] New Jersey District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
02/10/2011 International Fish Canners (Scotland) Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP 04/08/2011
02/10/2011 Global Protein Foods, Inc. [ARCHIVED] New Jersey District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
02/09/2011 Abba Pharma Inc. [ARCHIVED] Florida District Office Dietary Supplement/Adulterated Not Issued *
02/09/2011 Ancient Formulas Inc. [ARCHIVED] Kansas City District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
02/09/2011 Dean Blanchard Seafood, Inc. [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/09/2011 Vita Pure Inc [ARCHIVED] New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
02/09/2011 Nachman's Native Seafood [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/09/2011 Sanofi Aventis Deutschland GmbH [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Misbranded/Adulterated 08/14/2012
02/09/2011 Bioptigen Inc [ARCHIVED] Center for Devices and Radiological Health Devices/Misbranded 04/19/2016
02/09/2011 Steris Corporation [ARCHIVED] Center for Devices and Radiological Health Devices/Misbranded Not Issued *
02/08/2011 Toxin Technology, Inc. [ARCHIVED] Florida District Office CGMP/Adulterated 04/26/2012
02/08/2011 Hawkeye Jensen Inc [ARCHIVED] Philadelphia District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated 12/20/2011

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