FDA Inspection 828084 — James J. Yue
The FDA completed an inspection of James J. Yue on Mar 21, 2013 in New Haven, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- New Haven, CT (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2969 | 21 CFR 812.100 | No investigator protection - subject rights, safety, welfare |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |