483
Perceptive Informatics LLCFDA 483 - Perceptive Informatics LLC - October 04, 2013
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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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ID · 295702c3-8af6-4eb1-9e72-e510b48cfef9