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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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

Posted on February 08, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 21, 2011 Angiodynamics, Inc. Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
January 21, 2011 Inno Health Technology, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
January 21, 2011 Napoli LLC (dba Precision Reproduction Center for Devices and Radiological Health IRB (Institutional Review Board) Not Issued *
January 20, 2011 Shoney Scientific India Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
January 20, 2011 Laglove Sdn Bhd (M) aka LA Glove Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 20, 2011 Baxter Healthcare S.A. /dba Baxter Healthcare of Puerto Rico San Juan District Office CGMP for Finished Pharmaceuticals/Adulterated July 14, 2011
January 20, 2011 Scientific Protein Laboratories, LLC Minneapolis District Office CGMP for Deviations/Adulterated August 17, 2011
January 20, 2011 Cederroth Industrial Products AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
January 20, 2011 Baxter Healthcare Corporation San Juan District Office CGMP Regulations for Finished Pharmaceuticals/Adulterated July 14, 2011
January 19, 2011 Bull Frog Fish Farm, Llc.dba Bullfrog Fish Farm Eat My Fish Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated December 20, 2011
January 19, 2011 Fisherman's Catch Seafood Market Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 19, 2011 Upsher Smith Laboratories, Inc. Minneapolis District Office Labeling Drug Claims August 11, 2011
January 18, 2011 Tosoh Biosciences, Inc. Cincinnati District Office Premarket Approval/Adulterated/Misbranded November 04, 2011
January 18, 2011 D. Brickman Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated July 21, 2011
January 18, 2011 Marquette General Health System IRB Center for Devices and Radiological Health Investigational Device Exemptions Not Issued *
January 14, 2011 All American Pharmaceuticals Seattle District Office CGMP For Manufacturing, Packing, Labeling, or Holding for Dietary Supplements/Adulterated Not Issued *
January 13, 2011 Franklin Foods Inc. New England District Office Seafood HACCP/Adulterated July 07, 2011
January 13, 2011 Healthy Choice Island Blends, Inc. Los Angeles District Office HACCP/ Adulterated Not Issued *
January 12, 2011 PROLAC, INC. San Juan District Office CGMP/Manufacturing, Packing & Holding Human Food/Misbranded Not Issued *
January 11, 2011 Alphatec Spine, Inc. Center for Devices and Radiological Health Device/Misbranded Not Issued *


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