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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
December 02, 2010 LifeNet Health [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
December 02, 2010 Ocean Fresh LLC [ARCHIVED] San Francisco District Office Seafood HACCP November 25, 2011
December 02, 2010 Dong-A Otsuka Co. Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Acidified Foods/Adulterated March 25, 2011
December 02, 2010 Herbal-supplements-for-you [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded Not Issued *
December 02, 2010 Nutri Herb Inc [ARCHIVED] Florida District Office New Drug/Adulterated/Misbranded Not Issued *
December 01, 2010 Myron J. Diller Farm Philadelphia District Office Illegal Drug Residue Not Issued *
December 01, 2010 Advanced Surgical Design & Manufacture, Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP Manufacturer, Processsing, Packing, Holding/Devices/Adulterated Not Issued *
December 01, 2010 Airgas, Inc. [ARCHIVED] New Orleans District Office CGMP for Finished Pharmaceuticals/Adulterated May 18, 2011
November 30, 2010 OsteoSymbionics LLC [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
November 29, 2010 Optilasa SA [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 26, 2010 Shi Feng Zhang Dba Ginseng88 [ARCHIVED] Center for Food Safety and Applied Nutrition False & Misleading Claims/Misbranded Not Issued *
November 24, 2010 Sagami Rubber Industries Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated September 21, 2011
November 24, 2010 Eagle Health Supplies, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Adulterated November 06, 2012
November 22, 2010 WalkMed Infusion, LLC [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 19, 2010 Fujino Enterprises, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 18, 2010 AES Optics [ARCHIVED] New Orleans District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Not Issued *
November 18, 2010 VanderVeer Center [ARCHIVED] Center for Drug Evaluation and Research Misbranded/Labeling/Unauthorized Health Claims July 26, 2011
November 17, 2010 Phusion Projects Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 17, 2010 New Century Brewing Co [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 17, 2010 YeYa Products Corp [ARCHIVED] Florida District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
November 17, 2010 Bobby Chez, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP February 24, 2012
November 17, 2010 Align Technology Inc [ARCHIVED] San Francisco District Office Device/Misbranded July 27, 2015
November 17, 2010 Charge Beverages Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 17, 2010 United Brands Company Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
November 16, 2010 Empresas Y-nuina, Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions June 10, 2014
November 16, 2010 Eastern Cranial Affiliates, LLC [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Device Reporting/Misbranded June 08, 2011
November 15, 2010 Fischer Surgical Inc [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated December 19, 2011
November 12, 2010 Artesian Trout Farm [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Misbranded May 08, 2012
November 10, 2010 Eagle Products [ARCHIVED] Chicago District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated April 04, 2012
November 10, 2010 Oxygen Therapy Program [ARCHIVED] Florida District Office New Drug/False Misleading/Labeling/Misbranded Not Issued *
November 10, 2010 Friz-it Cold Storage, Inc. [ARCHIVED] Florida District Office Seafood HACCP September 03, 2015
November 10, 2010 Tws Marketing Group Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Federal Food, Drug and Cosmetic Act/Misbranded Not Issued *
November 10, 2010 Kabco Pharmaceuticals, Inc. [ARCHIVED] New York District Office CGMP in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
November 09, 2010 Monarch Labs, LLC [ARCHIVED] Los Angeles District Office CGMP for Medical Devices/QS/Adulterated April 03, 2012
November 09, 2010 Ultimate Formulations, Inc. dba Best Formulations [ARCHIVED] Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated October 29, 2013
November 09, 2010 Gunnell, Inc. [ARCHIVED] Detroit District Office Premarket Approval/Adulterated/Misbranded March 18, 2013
November 09, 2010 Lsg Sky Chefs, Inc [ARCHIVED] Dallas District Office Seafood HACCP Not Issued *
November 09, 2010 Race Street Foods, Inc [ARCHIVED] San Francisco District Office Seafood HACCP Not Issued *
November 09, 2010 Monarch Labs, LLC [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 08, 2010 Tony Crab King, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions May 17, 2011
November 08, 2010 Zooscape.com [ARCHIVED] New York District Office Unapproved New Drug Not Issued *
November 08, 2010 Soma Labs, Inc. [ARCHIVED] New Jersey District Office Dietary Supplement/Adulterated June 08, 2011
November 08, 2010 Pastime Lakes Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
November 08, 2010 Anchor Products Company, Inc [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded October 27, 2011
November 08, 2010 Fish Cove, Inc. [ARCHIVED] New York District Office Seafood HACCP Not Issued *
November 08, 2010 Swedish Bitters Herbs Company [ARCHIVED] Kansas City District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated Not Issued *
November 05, 2010 Minnesota Smoothies And More, LLC. [ARCHIVED] Minneapolis District Office Food Labeling Misbranded October 17, 2011
November 04, 2010 Inland Meats, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated September 19, 2011
November 03, 2010 Meiko Food Company Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 18, 2012
November 03, 2010 Fish Brothers, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP Not Issued *

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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