# FDA 483 - Roche Singapore Technical Operations Pte. Ltd. - November 14, 2025

Source: https://www.keypedia.com/records/483/roche-singapore-technical-operations-pte-ltd/630633b6-ebfb-4e41-b965-33148a170b83

> FDA 483 for Roche Singapore Technical Operations Pte. Ltd. on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roche Singapore Technical Operations Pte. Ltd.
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Roche Singapore Technical Operations Pte. Ltd., an API manufacturer in Singapore, revealed deficiencies in their quality unit procedures. The firm failed to adequately write and follow procedures for managing quality events related to damaged process-contacting equipment and lacked established time limits for reviewing work orders impacting GMP systems. This indicates a breakdown in their quality management system.

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- [483 - 2022-08-01](https://www.keypedia.com/records/483/roche-singapore-technical-operations-pte-ltd/a9662aa4-a6fe-402f-a06b-cad244103c24)

## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)

Company: https://www.keypedia.com/companies/roche-singapore-technical-operations-pte-ltd/e32730ce-85e1-4b01-8f9b-a8215d0593ca

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3