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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
June 29, 2009 Banyan Botanicals [ARCHIVED] Denver District Office New Drug/Labeling/Misbranded N/A *
June 29, 2009 Staten Island University Hospital IRB [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
June 26, 2009 Gaven Medical [ARCHIVED] New England District Office CGMP/QSR/Adulterated N/A *
June 26, 2009 FAVPEP LLC. dba Queenmar LLC. [ARCHIVED] Florida District Office Adulterated Food N/A *
June 26, 2009 Advanced Neuromodulation Systems, Inc [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 26, 2009 Gordon, Mark, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
June 25, 2009 Apotex Inc. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
June 25, 2009 Chesterfield Dairy [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
June 25, 2009 IntelSource Group Inc dba Electro Medical Technologies LLC [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated N/A *
June 25, 2009 Laboratoire Atlas Inc. [ARCHIVED] Center for Drug Evaluation and Research Pharmaceutical Manufacturing Facility/CGMP N/A *
June 24, 2009 Accumed Inc. [ARCHIVED] New Jersey District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated N/A *
June 23, 2009 Nutronix [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 23, 2009 Island Supplements [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 23, 2009 Apotheca Inc [ARCHIVED] Los Angeles District Office CGMP Manufacture, Processing, Packing or Holding/Adulterated N/A *
June 22, 2009 Circle T Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
June 18, 2009 Las Botanas [ARCHIVED] Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
June 18, 2009 Natren, Inc. [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 17, 2009 Niitikaya USA Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions N/A *
June 16, 2009 Zosa, Noli R., M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
June 16, 2009 International Desserts and Delicacies [ARCHIVED] Los Angeles District Office CGMP Regulation For Food/Adulterated N/A *



 

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