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

Source: https://www.globalkeysolutions.net/records/483/synergy-health-sterilisation-m-sdn-bhd/39ec3b51-b4a7-4893-a86d-a7f70c20e5e1

> FDA 483 for Synergy Health Sterilisation M SDN BHD on November 23, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synergy Health Sterilisation M SDN BHD
- Inspection Date: 2023-11-23
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/synergy-health-sterilisation-m-sdn-bhd/54b1c556-b637-4a61-9f87-2e3013a9c464

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd