FDA Inspection 669521 — Denver Health Medical Center
The FDA completed an inspection of Denver Health Medical Center on June 30, 2010 in Denver, CO. 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
- June 30, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 9225 | 21 CFR 606.171 | Biological product deviation report |