805292
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 15, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 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 |
| 6735 | 21 CFR 314.80(c)(1)(ii) | Failure to investigate serious, unexpected events |
| 6736 | 21 CFR 314.80(c)(1)(ii) | Submission of report follow-up |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |
| 6825 | 21 CFR 314.80(c)(1)(iii) | Non-applicant reports to applicant |
| 6829 | 21 CFR 314.80(c)(2) | Failure to report non-alert ADEs |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |