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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

Posted on June 01, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 26, 2010 Estrella Food Products, Inc. San Juan District Office Food Labeling/Insanitary Conditions/Adulterated/Misbranded Not Issued *
March 26, 2010 Liquid Manufacturing, L.L.C. Detroit District Office Acidified Foods/Adulterated January 07, 2011
March 26, 2010 Pierre Fabre Medicament Production Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated August 17, 2011
March 25, 2010 Today's Temptations, Inc. Chicago District Office Food Labeling/Misbranded Not Issued *
March 25, 2010 3CPM Company Inc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated December 13, 2010
March 24, 2010 Roxy Trading Inc Los Angeles District Office Adulterated Food Not Issued *
March 23, 2010 Simplydelicious Denver District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions January 19, 2011
March 23, 2010 Dornier Medtech America, Inc. Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded Not Issued *
March 18, 2010 Paragon Dx, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated May 11, 2010
March 17, 2010 James P. Johnston, CO, dba Midwest Ocular Prosthetics Center for Devices and Radiological Health Device/Misbranded, Not Issued *


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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