FDA Inspection 637133 — Presbyterian/St. Luke's Medical Center Donor Services
The FDA completed an inspection of Presbyterian/St. Luke's Medical Center Donor Services on November 24, 2009 in Denver, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 24, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 251 | 21 CFR 640.25(b) | Quality control |
| 376 | 21 CFR 640.120 | Alternative procedures |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |