FDA Inspection 853108 — Advanced Interventional Pain Ctr IRB
The FDA completed an inspection of Advanced Interventional Pain Ctr IRB on October 24, 2013 in Lafayette, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 24, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Lafayette, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7324 | 21 CFR 56.111(a)(4) | Informed consent sought |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7340 | 21 CFR 56.108(a)(3) | Prompt reporting of changes |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |