FDA Inspection 1008993 — MSD International GmbH (Singapore Branch)
The FDA completed an inspection of MSD International GmbH (Singapore Branch) on Mar 16, 2017 in Singapore. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 16, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |