FDA Inspection 1162551 — Centracare St. Cloud Hospital - Irb
The FDA completed an inspection of Centracare St. Cloud Hospital - Irb on Feb 18, 2022 in Saint Cloud, 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Cloud, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |