483
Sijo J. Parekattil, M.D.FDA 483 - Sijo J. Parekattil, M.D. - July 17, 2025
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Record Details
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.
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ID · 524387a3-69ca-424f-9610-55a85b9d807f