# FDA 483 - Takeda Manufacturing Singapore Pte. Ltd. - August 15, 2025

Source: https://www.globalkeysolutions.net/records/483/takeda-manufacturing-singapore-pte-ltd/28dfd9c1-4e7f-41ae-b111-b3c9e4354d10

> FDA 483 for Takeda Manufacturing Singapore Pte. Ltd. on August 15, 2025. 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: 2025-08-15
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: Takeda Manufacturing Singapore Pte. Ltd., a licensed biological drug manufacturer, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate investigations into manufacturing deviations, failures in validating manufacturing processes and cleaning procedures, and critical shortcomings within the quality unit, including a lack of written procedures and insufficient training oversight. These issues resulted in the release of impacted drug substance batches to the U.S. market and identified contamination risks.

## Related Documents

- [483 - 2022-11-10](https://www.globalkeysolutions.net/records/483/takeda-manufacturing-singapore-pte-ltd/d827a37b-bbdf-48aa-868d-4eff30361421)

## Related Officers

- [Kevin S Bradley](https://www.globalkeysolutions.net/people/kevin-s-bradley/9eab5130-a51d-4fa7-9c61-3a0dc47894c2)
- [Daniel Lagasse](https://www.globalkeysolutions.net/people/daniel-lagasse/7da2b202-7dda-4b86-bdd7-79f89414a079)
- [Investigator](https://www.globalkeysolutions.net/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Svetlana A. Shestopal](https://www.globalkeysolutions.net/people/svetlana-a-shestopal/5bf58ad5-04c7-4a9b-ae2d-8c6fa4034ddd)
- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8