FDA Inspection 773341 — Advanced Reproductive Medicine - University of Colorado Hospital
The FDA completed an inspection of Advanced Reproductive Medicine - University of Colorado Hospital on March 14, 2012 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |