FDA Inspection 761340 — UC Health Poudre Valley Hospital
The FDA completed an inspection of UC Health Poudre Valley Hospital on December 14, 2011 in Fort Collins, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Collins, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 376 | 21 CFR 640.120 | Alternative procedures |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9243 | 21 CFR 630.40(a) | Notification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |