• 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

2010 Warning Letters

Recently Posted | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005

Warning Letters issued in 2010

 

* 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
08/09/2010 Village Green Foods, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated 01/10/2012
08/09/2010 Diasol Inc [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
08/05/2010 BioVeda [ARCHIVED] Florida District Office Premarket Approval/Misbranded/Adulterated 02/10/2011
08/05/2010 Madama Oliva Srl [ARCHIVED] Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 09/14/2010
08/05/2010 FACTORIA DEL LAGO C.A. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
08/05/2010 Johnson Sea Products, Inc [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
08/04/2010 Sunic's Food, Inc. d.b.a Sun Food Trading Company [ARCHIVED] Seattle District Office Seafood HACCP/Adulterated Not Issued *
08/04/2010 Neoventa Medical AB [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
08/03/2010 Baxter International Inc. [ARCHIVED] Center for Biologics Evaluation and Research Misleading Efficacy Claim 06/23/2011
08/03/2010 Corporacion Del Mar [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HAACP/CGMP for Foods/Adulterated Not Issued *
08/03/2010 Pioneer Surgical Technology [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization 07/17/2012
08/03/2010 Cosmed Labs, Inc. [ARCHIVED] Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
08/02/2010 Pescamarca [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
08/02/2010 Saputo Cheese USA Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
08/02/2010 MP Biomedicals LLC [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded Not Issued *
07/30/2010 Vaill Brothers [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
07/30/2010 Scully, Sean M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials Not Issued *
07/29/2010 Dutch Valley Farms Denver District Office Illegal Drug Residue Not Issued *
07/29/2010 M.I. Tech Co Ltd [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting (MDR) Regulation Misbranded/Adulterated Not Issued *
07/29/2010 HSMG, Inc. D/b/a Smartinfuser USA [ARCHIVED] Dallas District Office Medical Device Reporting Regulation/Misbranded Not Issued *
07/29/2010 Golden Pacific Foods Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Insanitary Conditions/Adulterated/Misbranded Not Issued *
07/28/2010 Life Recovery Systems HD, LLC [ARCHIVED] Center for Devices and Radiological Health Medical Device/Lacks Premarket Approval/Adulterated/Misbranded 10/07/2010
07/27/2010 Eaton Manufacturing Corporation Dba Eaton Medical [ARCHIVED] New Orleans District Office Medical Device Reporting/Misbranded Not Issued *
07/27/2010 Gropoint Seafood Industries Sdn Bhd [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
07/27/2010 Biomet, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated 02/10/2011
07/26/2010 Nitrox, Inc. [ARCHIVED] Seattle District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
07/22/2010 Boca Pharmacal Inc. [ARCHIVED] Florida District Office Unapproved New Drug/Misbranded Not Issued *
07/22/2010 Flowers Baking Company of Villa Rica, LLC [ARCHIVED] Atlanta District Office Food Labeling Misbranded Not Issued *
07/21/2010 Euro Gourmet, Inc. [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated 04/28/2011
07/21/2010 Harlin, Stuart MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator Not Issued *
07/21/2010 U.F.S. Industries, Inc. (d/b/a) Sally Sherman Foods [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated 01/20/2011
07/21/2010 Big Daddy's Creamery LLC dba Theno's Dairy [ARCHIVED] Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions Not Issued *
07/20/2010 Haw Par Healthcare Limited [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/OTC Drug Manufacturing/Adulterated/Misbranded Not Issued *
07/20/2010 BCS African Wholesale Food Supply Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/09/2015
07/20/2010 Eminent Spine, LLC [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 02/06/2012
07/19/2010 Independent Review Consulting, Inc [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
07/19/2010 BCIW Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Device Reporting/Misbranded 05/11/2012
07/16/2010 ARJ Medical, Inc. [ARCHIVED] Florida District Office CGMP for Medical Devices/QS/Adulterated Not Issued *
07/15/2010 Shah Distributors, Inc. [ARCHIVED] Los Angeles District Office CGMP Regulation For Food/Adulterated Not Issued *
07/15/2010 RT Naturals, LLC [ARCHIVED] Los Angeles District Office Unapproved New Drug/Misbranded Not Issued *
07/15/2010 Knott's Wholesale Foods, Inc. [ARCHIVED] New Orleans District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded 06/02/2011
07/14/2010 VertiFlex, Inc. [ARCHIVED] Los Angeles District Office Premarket Approval/Adulterated 12/15/2010
07/13/2010 Cincinnati Sub-Zero Products Inc [ARCHIVED] Cincinnati District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated 01/17/2012
07/13/2010 Hill, Brian & Barbara Chicago District Office Illegal Drug Residue Not Issued *
07/12/2010 Circulatory Technology Inc [ARCHIVED] New York District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 02/17/2012
07/12/2010 Amstech Incorporated [ARCHIVED] Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
07/09/2010 Beckman, Robert L. New York District Office Illegal Drug Residue Not Issued *
07/09/2010 Med Prep Consulting, Inc [ARCHIVED] New Jersey District Office Failure to Register and List/Misbranded Not Issued *
07/08/2010 Florida Bottling, Inc. [ARCHIVED] Florida District Office New Drug/Drug Labeling/Misbranded 03/31/2011
07/06/2010 Western Milling Company [ARCHIVED] Los Angeles District Office CGMP for Medicated Feeds/Adulterated/Misbranded Not Issued *

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

-