FDA Inspection 1203427 — MSD International GmbH
The FDA completed an inspection of MSD International GmbH on March 24, 2023 in Clonmel. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clonmel (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |