FDA Inspection 832470 — Asentral Inc. IRB
The FDA completed an inspection of Asentral Inc. IRB on May 14, 2013 in Newburyport, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 14, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Newburyport, MA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7359 | 21 CFR 50.55(b) | Adequate assent of children; items to consider |