FDA Inspection 568544 — Alvarado Hospital Medical Center IRB
The FDA completed an inspection of Alvarado Hospital Medical Center IRB on January 14, 2009 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 14, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Diego, CA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |