FDA Inspection 1110514 — Naval Medical Center San Diego IRB
The FDA completed an inspection of Naval Medical Center San Diego IRB on November 20, 2019 in San Diego, CA. 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
- November 20, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Diego, CA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7297 | 21 CFR 56.109(b) | Information given to subjects |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |