FDA Inspection 952024 — UC Health Poudre Valley Hospital
The FDA completed an inspection of UC Health Poudre Valley Hospital on Nov 30, 2015 in Fort Collins, 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 30, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Collins, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |