# FDA 483 - MSD International GmbH - March 28, 2023

Source: https://www.keypedia.com/records/483/msd-international-gmbh/0d76bcd2-fe49-4540-a853-7347db067022

> FDA 483 for MSD International GmbH on March 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSD International GmbH
- Inspection Date: 2023-03-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: This FDA Form 483 report details three observations at MSD International GmbH T/A MSD Ireland (Biotech Dublin), a drug substance manufacturer in Swords, Ireland. The inspection revealed deficiencies in written procedures for deviation management, inadequate validation and control of QC microbiology testing, and insufficient sampling and testing for component identity and microbial contamination of drug substance bags. These issues indicate significant concerns regarding the firm's quality control and manufacturing processes.

## Related Officers

- [Yun Wu](https://www.keypedia.com/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)
- [investigator](https://www.keypedia.com/people/cassandra-l-abellard/e27aef11-adc6-449b-b7a8-f4c419549467)
- [Brian M. Janelsins](https://www.keypedia.com/people/brian-m-janelsins/6ae9b26e-5c53-4e67-a19a-2af3f30df039)

Company: https://www.keypedia.com/companies/msd-international-gmbh/b7e1b18b-94a9-4b5a-a415-2e6faf95795f

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