FDA Inspection 1171315 — MSD Ireland (Carlow)
The FDA completed an inspection of MSD Ireland (Carlow) on June 7, 2022 in Carlow. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 7, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Carlow (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |