FDA Inspection 786441 — Presbyterian/St. Luke's Medical Center Donor Services
The FDA completed an inspection of Presbyterian/St. Luke's Medical Center Donor Services on June 28, 2012 in Denver, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 28, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 198 | 21 CFR 640.2(c)(3) | Blood not stored between 1-6 deg / shipped 1-10 deg |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |
| 98 | 21 CFR 606.100(c) | Thorough investigations |