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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
April 20, 2010 Lasik Laser [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded July 29, 2011
April 20, 2010 Milky Way Farm [ARCHIVED] Atlanta District Office PHS Act Violation Not Issued *
April 20, 2010 Capricorn Pharma, Inc. [ARCHIVED] Baltimore District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated March 16, 2011
April 20, 2010 Care Holdings, Inc dba The LASIK Vision Institute [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
April 20, 2010 Vision Care Holdings, LLC [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting/Misbranded February 18, 2011
April 20, 2010 Rainbow Acres Farm [ARCHIVED] Philadelphia District Office PHS Act Violation Not Issued *
April 15, 2010 Wayne State University IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
April 15, 2010 Lactasoy Company Limited [ARCHIVED] Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
April 14, 2010 Lapp, John [ARCHIVED] Philadelphia District Office Illegal Drug Residue Not Issued *
April 13, 2010 Mid South Produce Distributors, LLC [ARCHIVED] New Orleans District Office CGMP/Adulterated November 16, 2010
April 13, 2010 Templeton Feed & Grain Inc. [ARCHIVED] Los Angeles District Office CGMP for Medicated Feeds/Adulterated Not Issued *
April 13, 2010 Super Body Care [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
April 13, 2010 Shreeji Homeo Clinic [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
April 12, 2010 Hospira, Inc. [ARCHIVED] Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated Not Issued *
April 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 *
April 09, 2010 J & F International, Inc. [ARCHIVED] Baltimore District Office Federal Food Drug and Cosmetic Act Violations, Compounded Drugs December 13, 2010
April 09, 2010 Pfizer Inc. Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
April 08, 2010 Physician Therapeutics, LLC [ARCHIVED] Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *
April 08, 2010 Shamrock Medical Solutions Group LLC [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
April 08, 2010 Bryant Ranch Prepack Inc. [ARCHIVED] Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *



 

Contact FDA

Office of Regulatory Science and Innovation

Carol D. Linden, PhD

Director

301-796-8527

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