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

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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