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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

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

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