FDA Inspection 732402 — Bay Regional Medical Center IRB
The FDA completed an inspection of Bay Regional Medical Center IRB on June 24, 2011 in Bay City, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 24, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bay City, MI (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 |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |