FDA Inspection 662780 — University of Vermont Medical Center
The FDA completed an inspection of University of Vermont Medical Center on May 20, 2010 in Burlington, VT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 20, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Burlington, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |