# FDA 483 - Novartis Singapore Pharmaceutical Manufacturing Pte. - Unknown Date

Source: https://www.keypedia.com/records/483/novartis-singapore-pharmaceutical-manufacturing-pte/cfecef16-10eb-4e5e-b344-e1b4fc0c988c

> FDA 483 for Novartis Singapore Pharmaceutical Manufacturing Pte. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novartis Singapore Pharmaceutical Manufacturing Pte.
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Novartis Singapore Pharmaceutical Manufacturing Pte Ltd. revealed significant deficiencies in quality control and manufacturing processes. The firm failed to adequately investigate root causes for deviations, leading to recurrent bioburden and endotoxin excursions, and approved analytical method transfers without scientific justification. Additionally, procedures for OOS investigations, critical material management, and adherence to production controls were found to be inadequate.

## Related Officers

- [Yue Wei](https://www.keypedia.com/people/yue-wei/058f9f8f-a35b-4f47-99a6-94004f5e64b1)
- [William Hallett](https://www.keypedia.com/people/william-hallett/05d39fb6-1492-4c8d-ad73-ab7ffc0c762a)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Sarah A. Johnson](https://www.keypedia.com/people/sarah-a-johnson/bb59c0e2-87ab-4958-8d33-463382ab7937)

Company: https://www.keypedia.com/companies/novartis-singapore-pharmaceutical-manufacturing-pte/fb15a25e-3d5c-408e-92a9-ba4b0906f449

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321