FDA Inspection 895364 — The Medical Center Of Aurora
The FDA completed an inspection of The Medical Center Of Aurora on Sep 12, 2014 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 117 | 21 CFR 606.121(f) | Labeling of blood products unsuitable for transfusion |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |