# FDA 483 - Takeda Manufacturing Singapore Pte. Ltd. - November 10, 2022

Source: https://www.keypedia.com/records/483/takeda-manufacturing-singapore-pte-ltd/d827a37b-bbdf-48aa-868d-4eff30361421

> FDA 483 for Takeda Manufacturing Singapore Pte. Ltd. on November 10, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Manufacturing Singapore Pte. Ltd.
- Inspection Date: 2022-11-10
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Takeda Singapore Pte. Ltd., a licensed biological manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately investigate unexplained discrepancies and negative trends, often lacking identified root causes, immediate corrections, or proper CAPA initiation and justification. Additionally, the quality control unit's responsibilities and procedures were not fully followed, with inadequate training in Good Documentation Practices and data integrity leading to multiple instances of missing or inconsistent electronic data.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Zuben Saana](https://www.keypedia.com/people/zuben-saana/7659361c-5011-4f84-b926-4fe2f1abd74a)

Company: https://www.keypedia.com/companies/takeda-manufacturing-singapore-pte-ltd/4ae048ca-a89e-47c7-b5a2-60d372157742

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