FDA Inspection 582128 — Baystate Medical Center IRB
The FDA completed an inspection of Baystate Medical Center IRB on May 12, 2009 in Springfield, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 12, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Springfield, MA (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |