# FDA 483 - MSD International GmbH - April 11, 2025

Source: https://www.keypedia.com/records/483/msd-international-gmbh/99e8d013-097e-44d7-a1ff-6845980d38cd

> FDA 483 for MSD International GmbH on April 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSD International GmbH
- Inspection Date: 2025-04-11
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: MSD International GmbH, a drug substance manufacturer in Co. Cork, Ireland, was cited for inadequate validation of a critical system supporting V116 (Capvaxive) monovalent bulk conjugate drug substance manufacturing operations. This deficiency led to multiple deviations related to design limitations, impacting product quality, including issues with time out of controlled storage, hold time, and tolerance checks. Several CAPAs were initiated to address these design errors, with most awaiting effectiveness verification.

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.keypedia.com/companies/msd-international-gmbh/a9448cbd-d3cc-4427-a1d5-22dc511c3c07

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