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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
12/02/2010 LifeNet Health [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
12/02/2010 Ocean Fresh LLC [ARCHIVED] San Francisco District Office Seafood HACCP 11/25/2011
12/02/2010 Dong-A Otsuka Co. Ltd. [ARCHIVED] Center for Food Safety and Applied Nutrition Acidified Foods/Adulterated 03/25/2011
12/02/2010 Herbal-supplements-for-you [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded Not Issued *
12/02/2010 Nutri Herb Inc [ARCHIVED] Florida District Office New Drug/Adulterated/Misbranded Not Issued *
12/01/2010 Myron J. Diller Farm Philadelphia District Office Illegal Drug Residue Not Issued *
12/01/2010 Advanced Surgical Design & Manufacture, Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP Manufacturer, Processsing, Packing, Holding/Devices/Adulterated Not Issued *
12/01/2010 Airgas, Inc. [ARCHIVED] New Orleans District Office CGMP for Finished Pharmaceuticals/Adulterated 05/18/2011
11/30/2010 OsteoSymbionics LLC [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
11/29/2010 Optilasa SA [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/26/2010 Shi Feng Zhang Dba Ginseng88 [ARCHIVED] Center for Food Safety and Applied Nutrition False & Misleading Claims/Misbranded Not Issued *
11/24/2010 Sagami Rubber Industries Co., Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 09/21/2011
11/24/2010 Eagle Health Supplies, Inc. [ARCHIVED] Los Angeles District Office CGMP/QSR/Adulterated 11/06/2012
11/22/2010 WalkMed Infusion, LLC [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/19/2010 Fujino Enterprises, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/18/2010 AES Optics [ARCHIVED] New Orleans District Office CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Not Issued *
11/18/2010 VanderVeer Center [ARCHIVED] Center for Drug Evaluation and Research Misbranded/Labeling/Unauthorized Health Claims 07/26/2011
11/17/2010 Phusion Projects Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
11/17/2010 New Century Brewing Co [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
11/17/2010 YeYa Products Corp [ARCHIVED] Florida District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
11/17/2010 Bobby Chez, Inc. [ARCHIVED] New Jersey District Office Seafood HACCP 02/24/2012
11/17/2010 Align Technology Inc [ARCHIVED] San Francisco District Office Device/Misbranded 07/27/2015
11/17/2010 Charge Beverages Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
11/17/2010 United Brands Company Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Illegal Food Additive/Adulteration Not Issued *
11/16/2010 Empresas Y-nuina, Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/10/2014
11/16/2010 Eastern Cranial Affiliates, LLC [ARCHIVED] Baltimore District Office CGMP/QSR/Medical Device Reporting/Misbranded 06/08/2011
11/15/2010 Fischer Surgical Inc [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated 12/19/2011
11/12/2010 Artesian Trout Farm [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Misbranded 05/08/2012
11/10/2010 Eagle Products [ARCHIVED] Chicago District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated 04/04/2012
11/10/2010 Oxygen Therapy Program [ARCHIVED] Florida District Office New Drug/False Misleading/Labeling/Misbranded Not Issued *
11/10/2010 Friz-it Cold Storage, Inc. [ARCHIVED] Florida District Office Seafood HACCP 09/03/2015
11/10/2010 Tws Marketing Group Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Federal Food, Drug and Cosmetic Act/Misbranded Not Issued *
11/10/2010 Kabco Pharmaceuticals, Inc. [ARCHIVED] New York District Office CGMP in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
11/09/2010 Monarch Labs, LLC [ARCHIVED] Los Angeles District Office CGMP for Medical Devices/QS/Adulterated 04/03/2012
11/09/2010 Ultimate Formulations, Inc. dba Best Formulations [ARCHIVED] Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 10/29/2013
11/09/2010 Gunnell, Inc. [ARCHIVED] Detroit District Office Premarket Approval/Adulterated/Misbranded 03/18/2013
11/09/2010 Lsg Sky Chefs, Inc [ARCHIVED] Dallas District Office Seafood HACCP Not Issued *
11/09/2010 Race Street Foods, Inc [ARCHIVED] San Francisco District Office Seafood HACCP Not Issued *
11/09/2010 Monarch Labs, LLC [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/08/2010 Tony Crab King, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 05/17/2011
11/08/2010 Zooscape.com [ARCHIVED] New York District Office Unapproved New Drug Not Issued *
11/08/2010 Soma Labs, Inc. [ARCHIVED] New Jersey District Office Dietary Supplement/Adulterated 06/08/2011
11/08/2010 Pastime Lakes Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
11/08/2010 Anchor Products Company, Inc [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded 10/27/2011
11/08/2010 Fish Cove, Inc. [ARCHIVED] New York District Office Seafood HACCP Not Issued *
11/08/2010 Swedish Bitters Herbs Company [ARCHIVED] Kansas City District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated Not Issued *
11/05/2010 Minnesota Smoothies And More, LLC. [ARCHIVED] Minneapolis District Office Food Labeling Misbranded 10/17/2011
11/04/2010 Inland Meats, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated 09/19/2011
11/03/2010 Meiko Food Company Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/18/2012
11/03/2010 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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