# FDA 483 - MSD International GmbH (Singapore Branch) - January 23, 2026

Source: https://www.globalkeysolutions.net/records/483/msd-international-gmbh-singapore-branch/2471240a-20d2-4743-be75-a9ccb5a2e9ca

> FDA 483 for MSD International GmbH (Singapore Branch) on January 23, 2026. 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: 2026-01-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: MSD International GmbH (Singapore Branch) received a Form 483 for significant deficiencies in its sterile drug product manufacturing operations. The observations highlight inadequate validation of aseptic and sterilization processes, insufficient environmental monitoring, and failures in quality control and laboratory investigations. These issues indicate a lack of robust controls to prevent microbiological contamination and ensure product quality.

## Related Documents

- [483 - 2021-09-03](https://www.globalkeysolutions.net/records/483/msd-international-gmbh-singapore-branch/61654fcd-a8cd-4a95-99b8-a4a44ce2cf88)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)
- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.globalkeysolutions.net/companies/msd-international-gmbh-singapore-branch/a3882132-e1a0-4326-bfe7-5f04605869cd

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