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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
07/25/2011 Kaiser Foodline LLC Dallas District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Not Issued *
07/25/2011 Spinetronics, LLC [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
07/22/2011 Bagels Forever, Inc [ARCHIVED] Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated 01/26/2012
07/22/2011 Great American Deli [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
07/21/2011 Sam's Marketing Inc. dba CoCo’s Fish Market [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/21/2011 Capt'n Chuncky's Crab Cake Company, LLC [ARCHIVED] Philadelphia District Office Seafood HACCP/Adulterated/Misbranded 01/06/2012
07/20/2011 Danny Johnson [ARCHIVED] Cincinnati District Office Illegal Drug Residue 12/15/2011
07/20/2011 SpecLinc, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
07/20/2011 Electro-Cap International, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
07/19/2011 Linda D. Bosserman [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator 10/01/2014
07/19/2011 Yamaya USA Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
07/18/2011 Isis Services, LLC [ARCHIVED] Center for Devices and Radiological Health Good Laboratory Practice (GLP) 02/07/2013
07/18/2011 Pacific Food, Inc [ARCHIVED] Cincinnati District Office Seafood HACCP/Adulterated/Misbranded Not Issued *
07/15/2011 Natural Guidance, LLC [ARCHIVED] Florida District Office Labeling/False & Misleading Claims/New Drug/Misbranded Not Issued *
07/15/2011 Lehigh Valley Technologies, Inc. [ARCHIVED] Philadelphia District Office CGMP for Finished Pharmaceuticals/Adulterated 01/09/2012
07/15/2011 Hardy Peanuts, Inc. [ARCHIVED] Atlanta District Office New Drug/Misbranded Not Issued *
07/15/2011 Advance Pierre Foods [ARCHIVED] Atlanta District Office CGMP Regulation For Food/Adulterated Not Issued *
07/15/2011 Grand Cakes Inc. [ARCHIVED] San Juan District Office Food Labeling/Adulterated/Misbranded 05/13/2013
07/15/2011 George Packing Company, Inc. [ARCHIVED] Seattle District Office Insanitary Conditions/Adulterated 01/31/2012
07/15/2011 Seattle Sperm Bank, LLC [ARCHIVED] Seattle District Office Human Cells, Tissues & Cellular Products Not Issued *
07/15/2011 Nutt Dairy [ARCHIVED] Denver District Office Illegal Drug Residue Not Issued *
07/14/2011 Nemschoff Chairs, Inc. [ARCHIVED] Minneapolis District Office CGMP for Medical Devices/QS/Adulterated 09/27/2016
07/14/2011 Shaping Beauty, Inc. / H & S GMP Factory [ARCHIVED] Philadelphia District Office Unapproved New Drug/Misbranded 01/03/2012
07/14/2011 Pharmaceutical Company Jelfa SA [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated 02/28/2013
07/14/2011 Rose Acre Farms, Inc. White County Egg Farm [ARCHIVED] Detroit District Office PHS Act/Shell Egg Regulation/Adulterated 02/12/2014
07/13/2011 Online-Smokes [ARCHIVED] Center for Tobacco Products Modified Risk Tobacco Products Not Issued *
07/13/2011 Roy and Louise Noble Dairy Farm [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
07/13/2011 Wayan Sumartini Saraswati [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 08/25/2011
07/12/2011 Valmont Dairy LLC [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
07/12/2011 Peace Medical Inc. [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated 07/05/2012
07/08/2011 Veeser Farms [ARCHIVED] Minneapolis District Office Illegal Drug Residue Not Issued *
07/07/2011 Cody L Emberton [ARCHIVED] Cincinnati District Office Illegal Drug Residue 03/08/2012
07/07/2011 Short Branch Farms LLC [ARCHIVED] Cincinnati District Office Illegal Drug Residue 02/07/2012
07/07/2011 El Guanaco Bakery & Cafe [ARCHIVED] Minneapolis District Office Labeling/False & Misleading Claims/Misbranded 07/08/2013
07/07/2011 Confidence Inc. [ARCHIVED] New York District Office CGMP/Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Regulation/Adulterated Not Issued *
07/07/2011 Northern Boulevard Corporation dba Despana Brand Foods [ARCHIVED] New York District Office Seafood HACCP/Adulterated Not Issued *
07/06/2011 Punjab Trading, Inc. [ARCHIVED] Seattle District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
07/06/2011 De Jong Dairy, Inc. [ARCHIVED] Detroit District Office Illegal Drug Residue 08/17/2011
07/06/2011 Michelson, Joseph B., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
07/06/2011 Sogo Foods Inc. [ARCHIVED] San Francisco District Office CGMP/Misbranded Not Issued *
07/05/2011 Redwood Memorial Hospital [ARCHIVED] San Francisco District Office Mammography Quality Standards Act Not Issued *
07/05/2011 Mayer Laboratories, Inc. [ARCHIVED] San Francisco District Office Lacks Premarket Approval Application/Adulterated/Misbranded 03/09/2012
07/01/2011 Premium Gold Flax Products & Processing Inc. [ARCHIVED] Minneapolis District Office Unapproved New Drug/Misbranded 08/17/2012
06/30/2011 Mai's Bakery Corp [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
06/30/2011 Signal Medical Corporation [ARCHIVED] Detroit District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/29/2011 Hunter Haven Farms [ARCHIVED] Chicago District Office Illegal Drug Residue Not Issued *
06/29/2011 JJ cake & Pastry, Corp [ARCHIVED] San Juan District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
06/29/2011 Cytosport Inc [ARCHIVED] San Francisco District Office False & Misleading Claims/Misbranded 11/29/2016
06/29/2011 First Commercial Kitchen, L.L.C. [ARCHIVED] San Francisco District Office Acidified Foods/Adulterated 10/30/2015
06/28/2011 MICROspecialties, Inc. [ARCHIVED] New England District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 10/01/2014

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