FDA 483 - Scitus Pharma Services Private Limited - March 21, 2025

An FDA inspection of Scitus Pharma Services Pvt., Ltd., a bioanalytical facility in Thirumudivakkam, Chennai, India, from March 17-21, 2025, revealed significant data integrity issues. The firm was cited for failing to report all relevant data, including undisclosed method validation runs and unlisted manually stopped sample analysis runs. Additionally, the inspection found inconsistencies in the application of criteria for sample reassays.