FDA Inspection 888939 — Rodo Medical Inc
The FDA completed an inspection of Rodo Medical Inc on August 1, 2014 in San Jose, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 1, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Jose, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 2933 | 21 CFR 812.43(a) | Investigator(s) not qualified |
| 2937 | 21 CFR 812.43(c)(1) | No curriculum vitae in investigator agreement |
| 2938 | 21 CFR 812.43(c)(2) | No info on relevant experience in investigator agreement |
| 2944 | 21 CFR 812.43(d) | Monitors not qualified |
| 2946 | 21 CFR 812.45 | Sponsor provide device information to investigators |
| 2952 | 21 CFR 812.46(b)(1) | No evaluation of unanticipated adverse effects |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |
| 2996 | 21 CFR 812.140(b)(4)(i) | Sponsor records re device use in non-significant risk study |
| 3000 | 21 CFR 812.140(b)(4)(v) | Sponsor records re QSR/GMP & non-significant risk studies |
| 3002 | 21 CFR 812.140(b)(5) | Sponsor records of adverse device effects & complaints |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |