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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 01, 2009 Sparkle Spring Water Inc. Atlanta District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions N/A *
July 01, 2009 Northwest Tofu, Inc. Seattle District Office Current Good Manufacturing Practice Regulations for Human Foods/Adulterated N/A *
June 30, 2009 J-Tel, Inc dba Buxton Foods Minneapolis District Office Labeling/False & Misleading Claims/Misbranded N/A *
June 29, 2009 Sylvane Inc. Center for Devices and Radiological Health Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 29, 2009 Banyan Botanicals Denver District Office New Drug/Labeling/Misbranded N/A *
June 29, 2009 Staten Island University Hospital IRB Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
June 26, 2009 FAVPEP LLC. dba Queenmar LLC. Florida District Office Adulterated Food N/A *
June 26, 2009 Gordon, Mark, M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
June 26, 2009 Advanced Neuromodulation Systems, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 26, 2009 Gaven Medical New England District Office CGMP/QSR/Adulterated N/A *
June 25, 2009 Apotex Inc. Center for Drug Evaluation and Research CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
June 25, 2009 Chesterfield Dairy Cincinnati District Office Illegal Drug Residue N/A *
June 25, 2009 Laboratoire Atlas Inc. Center for Drug Evaluation and Research Pharmaceutical Manufacturing Facility/CGMP N/A *
June 25, 2009 IntelSource Group Inc dba Electro Medical Technologies LLC Center for Devices and Radiological Health Premarket Approval/Adulterated N/A *
June 24, 2009 Accumed Inc. New Jersey District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated N/A *
June 23, 2009 Island Supplements Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 23, 2009 Apotheca Inc Los Angeles District Office CGMP Manufacture, Processing, Packing or Holding/Adulterated N/A *
June 23, 2009 Nutronix Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
June 22, 2009 Circle T Dairy Dallas District Office Illegal Drug Residue N/A *
June 18, 2009 Las Botanas Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated N/A *



 

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ICECI Warning Letters

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