FDA Inspection 1117824 — MSD International GmbH (Puerto Rico Branch) LLC
The FDA completed an inspection of MSD International GmbH (Puerto Rico Branch) LLC on February 26, 2020 in Las Piedras, PR. 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
- February 26, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Las Piedras, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |