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

Source: https://www.keypedia.com/records/483/siam-steri-services-co-ltd/376f4aaa-bd79-406f-b7ba-c6531826fdd9

> FDA 483 for SIAM STERI SERVICES CO., LTD on August 23, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SIAM STERI SERVICES CO., LTD
- Inspection Date: 2019-08-23
- Product Type: other
- Office Name: International Compliance Team
- Summary: 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.

## Related Documents

- [483 - 2019-08-23](https://www.keypedia.com/records/483/siam-steri-services-co-ltd/8b136079-4acc-47ed-9ea5-50134c883a66)

## Related Officers

- [Supervisory](https://www.keypedia.com/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)

Company: https://www.keypedia.com/companies/siam-steri-services-co-ltd/3a811a47-0b4f-47dc-9c7f-8185d69dd9e6

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321