FDA Inspection 746742 — Biomedical Research Inst. of America
The FDA completed an inspection of Biomedical Research Inst. of America on August 19, 2011 in San Diego, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 19, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- 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 |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |