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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 25, 2011 Cephazone Pharma LLC Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated June 21, 2012
April 25, 2011 Natural Path / Silver Wings, LLC New Orleans District Office CGMP/Unapproved New Drug/Dietary Supplement/Adulterated/Misbranded Not Issued *
April 22, 2011 ZOLL Medical Corporation New England District Office CGMP for Medical Devices/QS/Adulterated April 23, 2012
April 22, 2011 Solar Wide Industrial Ltd Center for Devices and Radiological Health CGMP/Quality System, Promotion and Advertsing, and Device Registration Not Issued *
April 22, 2011 Healthcare Authority of the City of Demopolis New Orleans District Office Mammography Quality Standards Act Not Issued *
April 22, 2011 Solar Wide Industrial Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
April 21, 2011 Regional Medical Center Cincinnati District Office CGMP for Blood & Blood Components & Finished Pharmaceuticals/Adulterated December 20, 2011
April 21, 2011 American Contract Systems Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated January 05, 2012
April 21, 2011 Tufo's To Go, LLC Cincinnati District Office Interstate Conveyance Sanitation Regulations August 24, 2011
April 20, 2011 Triple A Services, Inc. Chicago District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
April 20, 2011 Diaspora Tea & Herb dba Rishi Tea Minneapolis District Office New Drugs/Unauthorized NutrientContent February 03, 2012
April 20, 2011 ASI Medical, Inc. Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated March 23, 2012
April 20, 2011 Electrostim Medical Services Inc. Center for Devices and Radiological Health Adulterated Device/Misbranding/Quality System July 20, 2011
April 20, 2011 Zevex International, Inc. Denver District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded November 30, 2011
April 20, 2011 Tomaso's Specialty Foods San Francisco District Office Food Labeling/Misbranded Not Issued *
April 19, 2011 BNB MEDICAL CO., LTD. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
April 19, 2011 Durst Brothers, Inc. Minneapolis District Office New Animal Drug/Adulterated August 09, 2011
April 19, 2011 BIO LAB-ST. JOSEPH CORP San Juan District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
April 18, 2011 Refine, USA, LLC Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
April 18, 2011 Lifetech Resources LLC Los Angeles District Office Promotional Claims/New Drug/Misbranded Not Issued *



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