1032312
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 29, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Spokane, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2983 | 21 CFR 812.140(a)(2)(iii) | Investigator records of disposition of devices inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |