FDA Inspection 891505 — Wakai, Ronald, Ph. D., Clinical Investigator
The FDA completed an inspection of Wakai, Ronald, Ph. D., Clinical Investigator on September 5, 2014 in Madison, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 5, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Madison, WI (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |