FDA Inspection 1068494 — MSD International GmbH (Singapore Branch)
The FDA completed an inspection of MSD International GmbH (Singapore Branch) on October 12, 2018 in Singapore. 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
- October 12, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |