FDA 483 - MICROTROL STERILISATION SERVICES PRIVATE LIMITED - December 19, 2023

An FDA inspection of MICROTROL STERILISATION SERVICES PRIVATE LIMITED, a contract sterilization organization in Gurgaon, Haryana, revealed significant deficiencies across its quality system. The firm lacked a functional quality control unit, exhibited widespread data integrity failures, and failed to adequately validate its sterilization processes. Additionally, issues were noted in laboratory controls and equipment maintenance, indicating a systemic lack of control over drug product sterilization.