FDA Inspection 673484 — Sue Ellen Cox, M.D.
The FDA completed an inspection of Sue Ellen Cox, M.D. on June 25, 2010 in Chapel Hill, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Chapel Hill, NC (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7552 | 21 CFR 312.66 | Changes in research |