FDA 483 - Synergy Health Sterilisation M SDN BHD - November 23, 2023

An FDA inspection of Synergy Health Sterilisation M SDN BHD, a contract sterilizer in Kuala Ketil, Malaysia, revealed significant deficiencies in validation practices. The firm failed to adequately validate a sterilization process's operational qualification and could not provide validation for software used in production. These observations indicate a lack of robust quality system controls over critical manufacturing and software systems.