1006672
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Mumbai (India)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |