FDA 483 - Perceptive Informatics LLC - October 04, 2013

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.