FDA 483 - Perceptive Informatics LLC - February 23, 2012

An FDA inspection of Perceptive Informatics, Inc., a Contract Research Organization in Billerica, MA, revealed a significant failure to ensure studies were conducted in accordance with the protocol and investigational plan. The inspection found deficiencies in training, independent review processes, and documentation supporting study tasks. These issues indicate a lack of adherence to established study procedures.