FDA Inspection 1010680 — 3M Company IRB
The FDA completed an inspection of 3M Company IRB on Apr 14, 2017 in Saint Paul, MN. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7370 | 21 CFR 56.111(c) | Children as subjects |