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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
04/30/2010 Darr Feedlot Inc [ARCHIVED] Kansas City District Office CGMP for Medicated Feeds/Adulterated Not Issued *
04/29/2010 Vision Pharm, LLC [ARCHIVED] Florida District Office Lacks Approved New Drug Application/Adulterated/Misbranded Not Issued *
04/29/2010 Malda, Jeff [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
04/29/2010 Olsen Fish Company [ARCHIVED] Minneapolis District Office Seafood HACCP/Adulterated 11/15/2010
04/29/2010 L. Perrigo Company [ARCHIVED] Detroit District Office CGMP for Finished Pharmaceuticals/Adulterated 05/09/2011
04/29/2010 U Okada & Co Ltd [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated 05/29/2014
04/29/2010 Noxubee County Producers Inc. (dba Superior Fish Products) [ARCHIVED] New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated 08/19/2010
04/28/2010 Corner View Dairies [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
04/27/2010 Martin Feed Lot [ARCHIVED] Chicago District Office Illegal Drug Residue 09/14/2011
04/26/2010 La Estrellita Enterprises Incorporated [ARCHIVED] Denver District Office Acidified Foods/Adulterated Not Issued *
04/26/2010 Ephraim McDowell Regional Medical Center IRB [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
04/26/2010 Accurate Set Inc. [ARCHIVED] New Jersey District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
04/23/2010 St. Jude Medical Atrial Fibrillation Division Inc. [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (Sponsor)/Promoting Unapproved Use/Misbranded/Adulterated Not Issued *
04/23/2010 Elma Dairy, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
04/22/2010 Brookwood Medical Center [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
04/21/2010 Land Dairy, Inc. [ARCHIVED] Florida District Office Illegal Drug Residue Not Issued *
04/20/2010 Uv Flu Technologies, Inc. [ARCHIVED] Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the 2009 H1N1 Flu Virus Not Issued *
04/20/2010 Lasik Plus Vision Center [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded 07/29/2011
04/20/2010 Lasik Vision Institute (Boca Raton, FL) [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
04/20/2010 TLC Vision Corporation [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded 02/18/2011
04/20/2010 Lasik Laser [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded 07/29/2011
04/20/2010 Milky Way Farm [ARCHIVED] Atlanta District Office PHS Act Violation Not Issued *
04/20/2010 Capricorn Pharma, Inc. [ARCHIVED] Baltimore District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated 03/16/2011
04/20/2010 Care Holdings, Inc dba The LASIK Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
04/20/2010 Vision Care Holdings, LLC [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded 02/18/2011
04/20/2010 Rainbow Acres Farm [ARCHIVED] Philadelphia District Office PHS Act Violation Not Issued *
04/15/2010 Wayne State University IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
04/15/2010 Lactasoy Company Limited [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
04/14/2010 Lapp, John [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
04/13/2010 Mid South Produce Distributors, LLC [ARCHIVED] New Orleans District Office CGMP/Adulterated 11/16/2010
04/13/2010 Templeton Feed & Grain Inc. [ARCHIVED] Los Angeles District Office CGMP for Medicated Feeds/Adulterated Not Issued *
04/13/2010 Super Body Care [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
04/13/2010 Shreeji Homeo Clinic [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
04/12/2010 Hospira, Inc. [ARCHIVED] Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated Not Issued *
04/12/2010 E-holistic Health /Hanna Cooper [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthori zed Products Related to the H1N1 Flu Virus Not Issued *
04/09/2010 J & F International, Inc. [ARCHIVED] Baltimore District Office Federal Food Drug and Cosmetic Act Violations, Compounded Drugs 12/13/2010
04/09/2010 Pfizer Inc. Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
04/08/2010 Physician Therapeutics, LLC [ARCHIVED] Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *
04/08/2010 Shamrock Medical Solutions Group LLC [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
04/08/2010 Bryant Ranch Prepack Inc. [ARCHIVED] Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *
04/08/2010 The Children's Hospital Assoc. Transfusion Medicine Services [ARCHIVED] Denver District Office CGMP for Blood & Blood Products/Adulterated 08/08/2011
04/08/2010 Storz Medical, AG [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
04/07/2010 Wake Forest University Baptist Medical Center [ARCHIVED] Atlanta District Office Device/Adulterated Not Issued *
04/06/2010 Aloha Medicinals Inc. [ARCHIVED] San Francisco District Office New Animal Drug/Labeling/Misbranded/Adulterated Not Issued *
04/06/2010 Pure Med Spa [ARCHIVED] Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
04/05/2010 Medical Cosmetic Enhancements [ARCHIVED] Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded 05/21/2010
04/05/2010 All About You Medspa, LLC [ARCHIVED] Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded Not Issued *
04/05/2010 All About You Medspa, LLC [ARCHIVED] Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded 05/21/2010
04/05/2010 Spa 35 [ARCHIVED] Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded 05/21/2010
04/05/2010 Monarch Med Spa [ARCHIVED] Center for Drug Evaluation and Research Lipodissolve/False & Misleading Claims/Misbranded 05/21/2010

 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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