• 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

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
October 24, 2011 Procesadora El Cangrejito Del Mar C.A. (Procamar, C.A.) Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
October 24, 2011 Sea Fare Foods, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions January 10, 2013
October 21, 2011 Nurse Assist, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated August 17, 2012
October 21, 2011 Medical Compression Systems Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated August 16, 2012
October 21, 2011 Fremont Farms L.C. Kansas City District Office PHS Act/Violation/Adulterated Not Issued *
October 21, 2011 Cagenix New Orleans District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
October 21, 2011 Hanover Foods Corporation Baltimore District Office CGMP Regulation For Food/Adulterated Not Issued *
October 20, 2011 Eiber Radiology, Inc. Florida District Office Mammography Quality Standards November 10, 2011
October 20, 2011 Snokist Growers Seattle District Office CGMP for Food, Prepared, Packaged or Held Under Insanitary Conditions/Adulterated Not Issued *
October 20, 2011 Bacalao Brothers, Inc. dba New England Fish Market Florida District Office CGMP Regulation For Food/Adulterated Not Issued *
October 20, 2011 Beyer Lightning Fish Co. Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 17, 2012
October 19, 2011 Jenahexal Pharm GmbH Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated & Unapproved New Drugs Not Issued *
October 19, 2011 Evergreen Fresh Sprouts, LLC Seattle District Office Sprouts/Insanitary Conditions/Adulterated October 01, 2012
October 19, 2011 Simoes & Sons Dairy, Inc. San Francisco District Office New Animal Drugs/Adulterated Not Issued *
October 18, 2011 Jensen Farms Denver District Office Adulterated Food Not Issued *
October 18, 2011 Cracovia Co New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions August 27, 2013
October 17, 2011 Biomedica Diagnostics Inc Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 17, 2011 Health Advances USA, Inc. Los Angeles District Office CGMP Regulations For Dietary Supplements/Adulterated Not Issued *
October 17, 2011 Old Point Packing, Inc Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated May 31, 2012
October 17, 2011 Gro-Lan Farms Philadelphia District Office Illegal Drug Residue November 21, 2013



-