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

An FDA inspection of Sijo J. Parekattil, M.D. in Winter Garden, FL, a clinical investigator, revealed significant deficiencies in the conduct of Protocol CIP-002. Observations included failure to follow the investigational plan, such as enrolling a subject who did not meet inclusion criteria, prohibited advertising, and delayed reporting of a serious adverse event. Additionally, subject case history records were found to be inaccurate due to incorrect transcription of source data.