886613
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 25, 2014
- Fiscal Year
- 2014
- 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 |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |