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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
03/01/2010 Edwards Lifesciences, LLC [ARCHIVED] Center for Devices and Radiological Health Device/Misbranded Not Issued *
03/01/2010 Paddock Laboratories, Inc. [ARCHIVED] Center for Drug Evaluation and Research New Drugs Not Issued *
02/26/2010 Guidewire Technologies, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated 09/28/2010
02/25/2010 Cucina Fresca, Inc. [ARCHIVED] Seattle District Office Seafood HACCP Not Issued *
02/25/2010 Olympus Temmo Biomaterials Corporation - Mishima Factory [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/24/2010 Acquired Holding Inc [ARCHIVED] Cincinnati District Office Seafood HACCP Not Issued *
02/24/2010 Mueller Water Conditioning, Inc [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/24/2010 Centrix Pharmaceutical Inc [ARCHIVED] New Orleans District Office New Drug/Adulterated Not Issued *
02/23/2010 Tri-Med Laboratories Inc [ARCHIVED] New Jersey District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals Not Issued *
02/23/2010 Arnold's Service Company, Inc. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the 2009 H1N1 Flu Virus Not Issued *
02/23/2010 Seoul Trading Inc [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
02/23/2010 Arnold's Service Company, Inc. [ARCHIVED] Center for Devices and Radiological Health UnapprovedlUncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
02/23/2010 Karl Storz [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/23/2010 Pom Wonderful [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/23/2010 HMI Industries, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
02/22/2010 Beech-Nut Nutrition Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Guangzhou Yong Want Foods Ltd [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Schwan's Consumer Brands [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Sunsweet Growers Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Gerber Products Company [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Dreyer's Ice Cream Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Diamond Food Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Redco Foods, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 First Juice [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Sunsweet Growers Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Gerber Products Co [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Ken's Foods, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Pompeian, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Gorton's, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Spectrum Organic Products, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded 02/10/2011
02/22/2010 Pbm Products, LLC [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/22/2010 Fleminger Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded Not Issued *
02/18/2010 Stardust Dairy, LLC [ARCHIVED] Cincinnati District Office Illegal Drug Residue 05/30/2012
02/18/2010 Vertical Pharmaceuticals, Inc. [ARCHIVED] New Jersey District Office Premarket Approval/Misbranded/Adulterated 03/08/2011
02/18/2010 Lucky Farm Inc [ARCHIVED] Seattle District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
02/17/2010 Brennan And Mccoy [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Health, Wealth, & Happiness [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Unisource, Inc. [ARCHIVED] Denver District Office Unapproved New Drug/Misbranded Not Issued *
02/17/2010 Amasha [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Herbs, Heirlooms and Homebrew [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 White Egret, Inc. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Bobalee Originals Manufacturing [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Indian Mountain Center [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 A.J.'s Candles, Inc [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Harmony Cone [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Wholistic Health Solutions [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 International Ear Candle, LLC [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Wally's Natural Products, Inc. [ARCHIVED] San Francisco District Office Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 Home Remedies Solutions [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
02/17/2010 King Cone International [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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