FDA Inspection 842523 — M Health Fairview University Of Minnesota Medical Center, East Bank-Blood Bank
The FDA completed an inspection of M Health Fairview University Of Minnesota Medical Center, East Bank-Blood Bank on Jul 30, 2013 in Minneapolis, 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 30, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |