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

Between August 19 and August 23, 2019, the FDA conducted an inspection of Siam Steri Services Co., Ltd., a contract sterilization facility in Thailand. The inspection revealed several critical violations of quality system requirements under the Federal Food, Drug, and Cosmetic Act. The primary issue involved the inadequate validation of Ethylene Oxide sterilization processes. Specifically, the firm released hundreds of product batches without approved validation after modifying sterilization cycles in response to test failures.

Additional violations included a lack of documented investigations into process deviations and biological indicator failures. The facility also failed to maintain adequate corrective and preventive action (CAPA) records and lacked established procedures for reworking non-conforming or returned products. Furthermore, record-keeping was deficient, as sterilization details and lot numbers were often missing from device history records for reprocessed items.

While management at Siam Steri Services promised to correct the five specific observations noted during the inspection, the FDA requires the firm to conduct internal audits to identify and resolve all systemic quality issues. The company must provide a formal response detailing their corrective actions to ensure compliance with regulatory standards for product safety and sterilization integrity.