FDA Inspection 1247704 — Commonwealth Of Massachusetts Dept Of Mental Health CRRC
The FDA completed an inspection of Commonwealth Of Massachusetts Dept Of Mental Health CRRC on Aug 28, 2024 in Boston, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 28, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Boston, MA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7683 | 21 CFR 56.106(b)(2) | IRB registration information |