# FDA 483 - MSD Ireland (Carlow) - November 22, 2019

Source: https://www.keypedia.com/records/483/msd-ireland-carlow/f4627655-2699-40e9-86a0-5cf59b277f69

> FDA 483 for MSD Ireland (Carlow) on November 22, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MSD Ireland (Carlow)
- Inspection Date: 2019-11-22
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: MSD International GmbH, T/A MSD Ireland (Carlow) was cited for significant deficiencies in its manufacturing operations. The inspection revealed a failure to thoroughly review unexplained discrepancies, including an out-of-specification result for Pneumovax 23 and incomplete investigations into reported adverse events. Additionally, the firm lacked adequate laboratory controls, specifically regarding sampling plans and established hold times for endotoxin testing.

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## Related Officers

- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

Company: https://www.keypedia.com/companies/msd-ireland-carlow/e7f3036f-61c1-4e08-9e1a-213d968a50a2

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321