FDA Inspection 1012049 — Mass General Brigham Inc. IRB
The FDA completed an inspection of Mass General Brigham Inc. IRB on May 23, 2017 in Somerville, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Somerville, MA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7297 | 21 CFR 56.109(b) | Information given to subjects |