FDA Inspection 998973 — Presbyterian/St. Luke's Medical Center Donor Services
The FDA completed an inspection of Presbyterian/St. Luke's Medical Center Donor Services on January 26, 2017 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
- January 26, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |