FDA Inspection 735442 — Center for the Improvement of Human Functioning Intl IRB
The FDA completed an inspection of Center for the Improvement of Human Functioning Intl IRB on July 8, 2011 in Wichita, KS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Wichita, KS (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 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 |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7378 | 21 CFR 50.27(a) | Copy of consent form not provided |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7682 | 21 CFR 56.106(b)(1) | Senior officer (IRB overseer) information |
| 7692 | 21 CFR 56.106(e) | Changes in contact or chairperson information |