# FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - January 30, 2026

Source: https://www.globalkeysolutions.net/records/483/glpgcp-development-asia-pte-ltd/3a2a3d7b-ae6a-487c-9a90-0d731754259a

> FDA 483 for GLPGCP Development (Asia) Pte. Ltd. on January 30, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GLPGCP Development (Asia) Pte. Ltd.
- Inspection Date: 2026-01-30
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GLPGCP Development (Asia) Pte. Ltd. in Singapore identified two objectionable conditions related to bioanalytical activities and method validation. The firm failed to consistently follow standard operating procedures for documenting system suitability sample failures and inaccurately recorded method validation activities in source records.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ruben-c-ayala/6b5dadad-56b8-4af0-a65f-4685f71f0c8d)

Company: https://www.globalkeysolutions.net/companies/glpgcp-development-asia-pte-ltd/1f245fd5-d660-4d72-8019-5e993c078d9e

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