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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
11/03/2010 Energy Technology Development Ltd./Wicked Lasers [ARCHIVED] Center for Devices and Radiological Health Quality Control & Testing Program Not Issued *
11/03/2010 Showa Marine Inc [ARCHIVED] Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
11/02/2010 Dreisbach Enterprises Inc. [ARCHIVED] San Francisco District Office Seafood HACCP Not Issued *
11/01/2010 Kashmir Crown Baking LLC [ARCHIVED] New Jersey District Office CGMP Regulation For Food/Adulterated Not Issued *
11/01/2010 Kashmir Crown Baking LLC [ARCHIVED] New Jersey District Office CGMP Regulation For Food/Adulterated 06/09/2011
11/01/2010 Claris Lifesciences Limited [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated 08/14/2012
11/01/2010 Vitality Products Company Inc. [ARCHIVED] Philadelphia District Office Misbranded/Labeling/Unauthorized Health Claims 04/28/2011
11/01/2010 Hong's Merchandising Group, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/01/2010 Eckerd Seafood, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP Not Issued *
11/01/2010 Bioenergy, Inc [ARCHIVED] Minneapolis District Office Labeling/False & Misleading Claims/Misbranded 08/29/2011
10/29/2010 CP Pharmaceuticals, Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated 07/23/2012
10/28/2010 Wright Family Dairy Atlanta District Office Illegal Drug Residue Not Issued *
10/27/2010 Russell C. Davis Planetarium [ARCHIVED] Center for Devices and Radiological Health Laser Product Performance Standard Not Issued *
10/27/2010 Mexicali Cheese Corp. [ARCHIVED] New York District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
10/26/2010 Bay Island, Inc. [ARCHIVED] Minneapolis District Office CGMP for Foods/Adulterated 01/31/2012
10/26/2010 Pega Medical Inc. [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
10/22/2010 Pesnusan Cia Ltda [ARCHIVED] Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated 04/21/2011
10/21/2010 Hanover Foods Corporation [ARCHIVED] Baltimore District Office CGMP Regulation For Food/Adulterated Not Issued *
10/21/2010 Hong Chang Corporation [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
10/21/2010 Nobel Laboratories, LLC [ARCHIVED] Dallas District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *
10/20/2010 Pacific Fishing Company Limited [ARCHIVED] Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
10/20/2010 Axis Health Care LLC [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/20/2010 Scott, David F., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
10/20/2010 Vita-Herb Nutriceuticals, Inc. [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated 08/29/2012
10/20/2010 Lippton, Howard M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
10/18/2010 Mead Johnson Nutrition Company [ARCHIVED] Detroit District Office Infant Formula/Labeling 12/03/2010
10/15/2010 Living Naturally [ARCHIVED] Florida District Office New Drug/Adulterated/Misbranded Not Issued *
10/15/2010 Lighthouse Marina Partnership [ARCHIVED] New Jersey District Office Seafood HACCP 11/02/2012
10/15/2010 Prime Time Seafood, Inc [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated 06/27/2011
10/15/2010 Yunnan Hande Bio-Tech. Co. Ltd. [ARCHIVED] Center for Drug Evaluation and Research CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated 10/25/2011
10/15/2010 Quality Egg LLC [ARCHIVED] Kansas City District Office PHS Act Violation/Adulterated Not Issued *
10/14/2010 Blum's Spring Lake Fisheries [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Misbranded 07/29/2011
10/14/2010 Contract Pharmacal Corporation [ARCHIVED] New York District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded 04/18/2012
10/14/2010 Irish Acres Dairy LLC Detroit District Office Illegal Drug Residue 02/07/2011
10/13/2010 Bos Dairy LLC [ARCHIVED] Detroit District Office Illegal Drug Residue 05/09/2011
10/12/2010 Advanced Testing Laboratory Inc [ARCHIVED] Cincinnati District Office CGMP for Finished Pharmaceuticals/Adulterated 09/26/2011
10/12/2010 Cardio Renew Inc [ARCHIVED] Minneapolis District Office Unapproved New Drugs/Misbranded 08/29/2011
10/12/2010 Longevity Plus, LLC [ARCHIVED] Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
10/12/2010 Hormonal Health, LLC [ARCHIVED] Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
10/12/2010 Evenbetternow, LLC [ARCHIVED] Los Angeles District Office Unapproved New Drugs/Misbranded 05/03/2011
10/12/2010 Dr. Rhonda Henry [ARCHIVED] San Francisco District Office Unapproved New Drugs/Misbranded Not Issued *
10/12/2010 Artery Health Institute LLC [ARCHIVED] New York District Office Unapproved New Drugs/Misbranded Not Issued *
10/12/2010 World Health Products, Inc. [ARCHIVED] Denver District Office Unapproved New Drugs/Misbranded Not Issued *
10/12/2010 Maxam Nutraceutics [ARCHIVED] Seattle District Office Unapproved New Drugs/Misbranded Not Issued *
10/08/2010 Kanec USA, Inc. [ARCHIVED] Florida District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Not Issued *
10/08/2010 Rx-promotion [ARCHIVED] Center for Drug Evaluation and Research Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
10/07/2010 Biostructures, LLC [ARCHIVED] Los Angeles District Office Premarket Approval/Adulterated/Misbranded 12/11/2012
10/06/2010 Thanh Son Tofu Inc [ARCHIVED] Los Angeles District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
10/06/2010 Fresh Express Incorporated [ARCHIVED] San Francisco District Office False & Misleading Claims/Misbranded Not Issued *
10/05/2010 Longway Farm New England District Office Illegal Drug Residue 10/26/2010

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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