# FDA 483 - Roche Singapore Technical Operations Pte. Ltd. - August 01, 2022

Source: https://www.keypedia.com/records/483/roche-singapore-technical-operations-pte-ltd/a9662aa4-a6fe-402f-a06b-cad244103c24

> FDA 483 for Roche Singapore Technical Operations Pte. Ltd. on August 01, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Roche Singapore Technical Operations Pte. Ltd.
- Inspection Date: 2022-08-01
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Roche Singapore Technical Operations Pte. Ltd. in Singapore was inspected by the FDA, revealing significant deficiencies in manufacturing controls for drug substances. The inspection identified issues with equipment cleaning validation, material segregation, root cause investigations, production procedures, data integrity, and facility design. These observations indicate a moderate level of severity, impacting the quality and purity of drug substances.

## Related Officers

- [Wendy Tan, PhD, Microbiologist](https://www.keypedia.com/people/wendy-tan-phd-microbiologist/24f63b1c-33e5-440c-9853-2a18c141afa3)
- [Michael A Moses, PhD, Biologist](https://www.keypedia.com/people/michael-a-moses-phd-biologist/baa0c916-00f7-4713-8aee-7c095d86d44c)
- [Katherine Jacobitz, IB Director](https://www.keypedia.com/people/katherine-jacobitz-ib-director/de115f4d-08de-4927-a17b-8b1a1e4de1c0)
- [Riley Myers, Ph.D.; Lead Biologist](https://www.keypedia.com/people/riley-myers-phd-lead-biologist/f9f7b2db-0820-4e31-95bf-27aa2b6568ea)

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

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