FDA EIR - Perceptive Informatics LLC - October 04, 2013

An FDA inspection of Perceptive Informatics, Inc. in Billerica, MA, was conducted from September 26 to October 4, 2013. This high-priority pre-approval inspection focused on sponsor monitor data-validation for an imaging core laboratory, guided by Good Clinical Practice (GCP) regulations and specific FDA compliance programs. The inspection identified a significant finding, resulting in the issuance of a Form FDA 483. The main violation was the "Failure to ensure the study is conducted in accordance with the protocol and/or investigational plan," specifically referencing 21 CFR 312.50. Perceptive Informatics conducted data reviews that influenced study outcomes outside the scope defined in the Independent Review Charter and project plan, without a pre-specified procedure. This involved collaborative review sessions with the study sponsor that led to image re-reviews and re-assessments. Additionally, minor issues were noted concerning insufficient documentation of study-related correspondence, including critical phone calls, and an instance where a reviewer's training did not adhere to the required "consensus" approach outlined in the project plan. Management was informed of the findings and their responsibility to promptly correct all violations. Key required actions include documenting all study correspondence thoroughly and ensuring strict adherence to established reviewer training methodologies. The company committed to submitting a written response to the FDA 483 within 15 business days. Furthermore, in response to a previous inspection, Perceptive Informatics had already begun implementing measures to address issues related to information provision, including revised SOPs and contract language.