# FDA 483 - MSD International GmbH (Singapore Branch) - June 04, 2018

Source: https://www.keypedia.com/records/483/msd-international-gmbh-singapore-branch/2d68fcc1-12ab-42c3-b7e4-4d4deed5051c

> FDA 483 for MSD International GmbH (Singapore Branch) on June 04, 2018. 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: 2018-06-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of MSD International GmbH (Singapore Branch) revealed a lack of written procedures for production and process controls to ensure drug product quality. The firm failed to validate adequate controls over process design, leading to out-of-specification impurity levels in a drug substance. This issue impacted numerous lots, necessitating a temporary halt in manufacturing and the implementation of interim controls.

## Related Documents

- [483 - 2018-06-08](https://www.keypedia.com/records/483/msd-international-gmbh-singapore-branch/85cc3ff5-cc77-466b-bef1-80a7c459a8b5)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.keypedia.com/companies/msd-international-gmbh-singapore-branch/acbc6490-ca0c-4304-8210-a35e4c4cbd79

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