PRACS Institute, Ltd.August 6, 2012

FDA 483 - PRACS Institute, Ltd. - August 06, 2012

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Record Details

An FDA inspection of PRACS Institute, Ltd., a Contract Research Organization in Fargo, ND, revealed a significant failure to address and resolve issues concerning study samples for a specific study. This observation indicates potential deficiencies in the firm's quality control or data management processes.

Company: PRACS Institute, Ltd.
Inspection Date: August 6, 2012
Product Type: Drugs
Office: Minneapolis District Office
People: Xikui Chen (Pharmacologist at FDA)
Darren D. Holaday

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ID · be726d70-9c2e-4c51-bb16-5d892c61568d