FDA Inspection 820354 — Lenoir Memorial Hospital IRB
The FDA completed an inspection of Lenoir Memorial Hospital IRB on February 12, 2013 in Kinston, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 12, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Kinston, NC (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7337 | 21 CFR 56.115(b) | Retention of records |