FDA Inspection 1117824 — MSD International GmbH (Puerto Rico Branch) LLC
The FDA completed an inspection of MSD International GmbH (Puerto Rico Branch) LLC on Feb 26, 2020 in Las Piedras, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 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 |