FDA Inspection 868586 — UCARM Stapleton Clinic
The FDA completed an inspection of UCARM Stapleton Clinic on March 3, 2014 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
- March 3, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |