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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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2007 Warning Letters

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Warning Letters for 2007

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* 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 02, 2009

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 04, 2007 Washington Hospital Center Baltimore District Office CGMP for Blood & Blood Components/Adulterated N/A *
October 03, 2007 Deep Blue Seafood Denver District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
October 02, 2007 iScreen, LLC New Orleans District Office CGMP/Quality System/Adulterated N/A *
October 02, 2007 Dialysis Dimensions Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 01, 2007 Warsaw Orthopedic Inc Detroit District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 01, 2007 Bradford, Michael, MD Center for Devices and Radiological Health Clinical Investigator N/A *
October 01, 2007 Medtronic Incorporated Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
September 28, 2007 Efficas, Inc. Center for Food Safety and Applied Nutrition Labeling & Promotional Claims N/A *
September 28, 2007 Cameron-Miller, Inc. Chicago District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
September 28, 2007 Healthway Home Products, Inc New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 28, 2007 GE Infrastructure, Water & Process Technologies Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 28, 2007 Med-South Pharmacy Inc. New Orleans District Office Pharmacy Compounding/New Drug/Adulterated/Misbranded N/A *
September 26, 2007 Golden View LP Los Angeles District Office Animal Sale for Slaughter as Food/Adulterated N/A *
September 26, 2007 Duane Oxendale Detroit District Office Animals for Sale for Slaughter as Food/Adulterated N/A *
September 25, 2007 Aquamar Fisheries, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 25, 2007 East Coast Meat & Seafood Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 24, 2007 Alternative Health Approaches Los Angeles District Office Drug Labeling/Promotional Claims/Misbranded N/A *
September 24, 2007 Chiu Technical Corp. New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 24, 2007 SCM True Air Technologies LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 21, 2007 Ben J. Weaver New York District Office Animal Sale for Slaughter as Food/Feed/Drug/adulterated/ N/A *


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ICECI Warning Letters

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Food and Drug Administration

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