FDA Inspection 772096 — University of Vermont Medical Center
The FDA completed an inspection of University of Vermont Medical Center on February 23, 2012 in Burlington, VT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Burlington, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 9225 | 21 CFR 606.171 | Biological product deviation report |