# FDA 483 - MSD International GmbH (Singapore Branch) - September 03, 2021

Source: https://www.keypedia.com/records/483/msd-international-gmbh-singapore-branch/61654fcd-a8cd-4a95-99b8-a4a44ce2cf88

> FDA 483 for MSD International GmbH (Singapore Branch) on September 03, 2021. 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: 2021-09-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MSD International GmbH Singapore Branch, a sterile drug product manufacturer in Singapore, was cited for significant deficiencies during an FDA inspection. Observations included failures in aseptic processing procedures, lack of assurance in manufacturing process consistency, inadequate written procedures for foreign matter investigation, and insufficient verification of supplier COAs. Additionally, the facility exhibited design and maintenance issues, posing risks to product quality and sterility.

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## Related Officers

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd