FDA Inspection 898990 — Inland Institute of Aesthetic Dentistry IRB
The FDA completed an inspection of Inland Institute of Aesthetic Dentistry IRB on October 16, 2014 in Upland, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 16, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Upland, CA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7309 | 21 CFR 56.111(a)(1) | Risks minimized by sound research design |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7326 | 21 CFR 56.111(a)(6) | Monitoring of data collected |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7384 | 21 CFR 50.25(b)(1) | Statement of risks |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |
| 7658 | 21 CFR 50.25(b)(2) | Termination by investigator |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |