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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

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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 20, 2010 Lasik Vision Institute (Boca Raton, FL) Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
April 20, 2010 Uv Flu Technologies, Inc. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the 2009 H1N1 Flu Virus Not Issued *
April 20, 2010 Capricorn Pharma, Inc. Baltimore District Office CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated March 16, 2011
April 20, 2010 Milky Way Farm Atlanta District Office PHS Act Violation Not Issued *
April 20, 2010 Rainbow Acres Farm Philadelphia District Office PHS Act Violation Not Issued *
April 20, 2010 Lasik Laser Center for Devices and Radiological Health Medical Device Reporting/Misbranded July 29, 2011
April 15, 2010 Wayne State University IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
April 15, 2010 Lactasoy Company Limited Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
April 14, 2010 Lapp, John Philadelphia District Office Illegal Drug Residue Not Issued *
April 13, 2010 Super Body Care Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
April 13, 2010 Mid South Produce Distributors, LLC New Orleans District Office CGMP/Adulterated November 16, 2010
April 13, 2010 Templeton Feed & Grain Inc. Los Angeles District Office CGMP for Medicated Feeds/Adulterated Not Issued *
April 13, 2010 Shreeji Homeo Clinic Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
April 12, 2010 Hospira, Inc. Atlanta District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated Not Issued *
April 12, 2010 E-holistic Health /Hanna Cooper 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. 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 Not Issued *
April 08, 2010 The Children's Hospital Assoc. Transfusion Medicine Services Denver District Office CGMP for Blood & Blood Products/Adulterated August 08, 2011
April 08, 2010 Physician Therapeutics, LLC Los Angeles District Office New Drug/Labeling/Misbranded/Adulterated Not Issued *
April 08, 2010 Shamrock Medical Solutions Group LLC New England District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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