FDA 483 - Sijo J. Parekattil, M.D. - July 17, 2025

An FDA inspection of Sijo J. Parekattil, M.D., a clinical investigator, revealed significant deviations from an investigational plan and protocol for Protocol CIP-002. Observations included issues with subject eligibility, prohibited advertising, delayed serious adverse event reporting, and inaccurate subject case history records. These findings indicate a lack of adherence to clinical trial regulations and good clinical practice.