483
Perceptive Informatics LLCPerceptive Informatics LLC – FDA 483, Oct 4, 2013
Record Details
An FDA inspection of Perceptive Informatics, Inc. in Billerica, MA, conducted from September 26 to October 4, 2013, identified a significant issue. The firm failed to ensure a study was conducted in accordance with its protocol and investigational plan. This involved conducting data reviews that were not prescribed by the Independent Review Charter and project plan.
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