# FDA 483 - MSD Ireland (Carlow) - June 07, 2022

Source: https://www.keypedia.com/records/483/msd-ireland-carlow/06a78232-49b5-4d3f-b580-0ec8e67aa6c0

> FDA 483 for MSD Ireland (Carlow) on June 07, 2022. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MSD Ireland (Carlow)
- Inspection Date: 2022-06-07
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of MSD International GmbH T/A MSD Ireland in Carlow, Ireland, a drug/biologic establishment, revealed two significant observations. The firm was cited for deficiencies in environmental monitoring systems within aseptic processing areas and for not establishing adequate control procedures to monitor manufacturing processes that cause variability in drug product characteristics.

## Related Documents

- [483 - 2019-11-22](https://www.keypedia.com/records/483/msd-ireland-carlow/f4627655-2699-40e9-86a0-5cf59b277f69)
- [483 - 2024-05-28](https://www.keypedia.com/records/483/msd-ireland-carlow/922898c1-29bf-4b7d-b471-f9c7a445ef25)
- [483 - Unknown Date](https://www.keypedia.com/records/483/msd-ireland-carlow/6f61a3fb-85c7-4632-9294-d490629ec873)
- [483 - 2025-04-01](https://www.keypedia.com/records/483/msd-ireland-carlow/dd59e938-7401-4e83-8a6b-5cffaf74a0e3)

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4