• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
November 10, 2011 RMO, Inc. Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated June 08, 2012
November 10, 2011 Great Oceans, LLC New York District Office Seafood HACCP/Adulterated Not Issued *
November 10, 2011 Golden Temple of Oregon, LLC - Tea Facility Seattle District Office CGMP for Dietary Supplements/New Drug Claims July 31, 2012
November 10, 2011 The Sandwich Man, Inc. New Orleans District Office CGMP Regulation For Food/Adulterated/Misbranded Not Issued *
November 10, 2011 Tonka Seafoods, Inc. Seattle District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
November 09, 2011 Ocean Group Inc. (dba Ocean Fresh Fish & Seafood Marketing) Los Angeles District Office Seafood HACCP/Adulterated September 17, 2012
November 08, 2011 Lakeland Bakery, Inc. Minneapolis District Office Food Labeling/Misbranded September 18, 2012
November 08, 2011 Greenville Loop Seafood, Inc. Atlanta District Office CGMP Regulation For Food/Adulterated Not Issued *
November 08, 2011 Country Maid, Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 12, 2013
November 07, 2011 Blue Water Connection Seafood Corp. Florida District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
November 07, 2011 Silver Moon Springs LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 07, 2011 Dongguan Dalang Vigor Electronics Mfy. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 07, 2011 Son-D-Farms Inc Minneapolis District Office Illegal Drug Residue/Adulterated January 23, 2012
November 04, 2011 Diaz, Leslie, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 03, 2011 Tan Hung Bakery San Francisco District Office Labeling/False & Misleading Claims/Misbranded August 06, 2012
November 01, 2011 Beckman Coulter, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated January 21, 2014
November 01, 2011 Pace Tech, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
November 01, 2011 CJ Labs, Inc. Florida District Office CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 01, 2011 Frank L Harter & Sons Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 01, 2011 Rainbow LTD, Inc. dba PN Medical Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



-