# FDA 483 - MSD International GmbH (Singapore Branch) - June 20, 2025

Source: https://www.globalkeysolutions.net/records/483/msd-international-gmbh-singapore-branch/78580e59-50b5-4514-838b-522d97a36a29

> FDA 483 for MSD International GmbH (Singapore Branch) on June 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSD International GmbH (Singapore Branch)
- Inspection Date: 2025-06-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: MSD International GmbH (Singapore Branch), a drug substance manufacturer, received an FDA Form 483 observation regarding its quality systems. The inspection found that qualified utilities were not appropriately monitored, specifically noting that alert limits for water systems had not been updated in 17 years. This indicates a potential deficiency in maintaining current monitoring standards for critical manufacturing utilities.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/msd-international-gmbh-singapore-branch/535e8364-58b1-4837-8520-8a0295f0d439)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

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

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