FDA Inspection 741768 — Presbyterian/St. Luke's Medical Center Donor Services
The FDA completed an inspection of Presbyterian/St. Luke's Medical Center Donor Services on August 23, 2011 in Denver, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 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 |
| 251 | 21 CFR 640.25(b) | Quality control |
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |
| 9288 | 21 CFR 640.21(a) | Eligibility of platelet donors |
| 98 | 21 CFR 606.100(c) | Thorough investigations |