FDA 483 - SIAM STERI SERVICES CO., LTD - August 23, 2019

An FDA inspection of SIAM STERI SERVICES CO., LTD in Phan Thong, Chon Buri, Thailand, a contract sterilizer, revealed significant deficiencies in their Ethylene Oxide (ETO) sterilization processes. The firm failed to adequately validate sterilization cycles and software, properly investigate biological indicator failures, document corrective actions, or maintain adequate records for rework and re-sterilization activities. These issues indicate a severe lack of control over critical sterilization processes and quality system documentation.