635643
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 2, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Waterford Township, MI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14521 | 21 CFR 812.36(e) | No IRB approval for treatment use |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |