FDA Inspection 654411 — Scully, Sean P.
The FDA completed an inspection of Scully, Sean P. on April 15, 2010 in Jacksonville, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 15, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Jacksonville, NC (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 3025 | 21 CFR 812.150(a)(3) | No investigator progress reports |
| 3064 | 21 CFR 812.140(a)(4) | Investigator protocol records inadequate |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |