# FDA 483 - MSD International GmbH (Singapore Branch) - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/msd-international-gmbh-singapore-branch/535e8364-58b1-4837-8520-8a0295f0d439

> FDA 483 for MSD International GmbH (Singapore Branch) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MSD International GmbH (Singapore Branch)
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: MSD International GmbH (Singapore Branch), an API manufacturer, was cited for six observations during an FDA inspection. The findings primarily concern significant deficiencies in data review procedures, process validation, computer system controls, complaint investigations, cleaning procedures, and microbiological testing methods. These issues indicate a lack of robust quality control and data integrity practices.

## Related Documents

- [483 - 2025-06-20](https://www.globalkeysolutions.net/records/483/msd-international-gmbh-singapore-branch/78580e59-50b5-4514-838b-522d97a36a29)

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/msd-international-gmbh-singapore-branch/8ac4b93f-053e-4462-be8f-63d2ee5d9a0d

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1