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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 24, 2007 Davol, Inc. New England District Office CGMP for Medical Devices/QS/Adulterated N/A *
April 17, 2007 Langers Juice Co. Los Angeles District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
April 17, 2007 STM Trading Corporation San Juan District Office Seafood HACCP/Adulterated N/A *
April 16, 2007 Medico Labs, Inc. New Jersey District Office CGMP/Deviations/Adulterated N/A *
April 16, 2007 Bothwell Regional Health Center Kansas City District Office CGMP Deviations/Additional Standards for Human Blood and Blood Products/Adulterated N/A *
April 13, 2007 PharMEDium Services, LLC Dallas District Office New Drug N/A *
April 12, 2007 Sun Biomedical Laboratories, Inc. New Jersey District Office CGMP for Medical Devices/QSR/Adulterated/Misbranded N/A *
April 10, 2007 AmeriWater, Inc. Cincinnati District Office Premarket Approval/Misbranded/Adulterated N/A *
April 10, 2007 Kemp Cattle Dallas District Office Edible Tissues/Adulterated N/A *
April 10, 2007 Stroup, Sreven L.,M.D. Center for Devices and Radiological Health Investigational Device Exemptions N/A *
April 09, 2007 Clark Research and Development, Inc. New Orleans District Office Current Good Manufacturing Practice for Medical Devices N/A *
April 09, 2007 L & M Cattle Co. Dallas District Office Edible Tissues/Adulterated N/A *
April 04, 2007 Redux Beverages, LLC Los Angeles District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded N/A *
April 04, 2007 Drew Scientific Co. Limited Center for Devices and Radiological Health Current Good Manufacturing Practice/Adulterated N/A *
April 03, 2007 Davis, Thomas P, M.D. Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) N/A *
April 03, 2007 Iren Corporation Philadelphia District Office Current Good Manufacturing Practice Regulation/Adulterated N/A *
April 02, 2007 LifeCare Technologies, Inc. Florida District Office QSR/Medical Devices/Misbranded N/A *
March 30, 2007 Everything Spelt Company, Inc. New York District Office False & Misleading Claims/Misbranded N/A *
March 30, 2007 ViroMed Laboratories Minneapolis District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
March 29, 2007 Akorn, Incorporated Chicago District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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Rockville, MD 20857
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