# FDA 483 - MSD Ireland (Carlow) - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/msd-ireland-carlow/6f61a3fb-85c7-4632-9294-d490629ec873

> FDA 483 for MSD Ireland (Carlow) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: MSD Ireland (Carlow)
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MSD International GmbH T/A MSD Ireland (Carlow) received three observations during an FDA inspection. The observations highlight deficiencies in aseptic processing controls, specifically regarding first air operations and smoke studies for a vial filling line. Additionally, the firm's visual inspection process for drug product was found to lack adequate process controls for rejected vials.

## Related Documents

- [483 - 2019-11-22](https://www.globalkeysolutions.net/records/483/msd-ireland-carlow/f4627655-2699-40e9-86a0-5cf59b277f69)
- [483 - 2022-06-07](https://www.globalkeysolutions.net/records/483/msd-ireland-carlow/06a78232-49b5-4d3f-b580-0ec8e67aa6c0)
- [483 - 2025-04-01](https://www.globalkeysolutions.net/records/483/msd-ireland-carlow/dd59e938-7401-4e83-8a6b-5cffaf74a0e3)

## Related Officers

- [Jennifer E. Veenhof](https://www.globalkeysolutions.net/people/jennifer-e-veenhof/b47ea5e3-f4cd-44fd-b6a0-0f8251c26d10)
- [Ralph M. Bernstein](https://www.globalkeysolutions.net/people/ralph-m-bernstein/72173dfb-24ae-42a1-af9e-1dc7da02ed87)
- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd