FDA Inspection 794753 — Montrose Memorial Hospital Blood Bank
The FDA completed an inspection of Montrose Memorial Hospital Blood Bank on August 3, 2012 in Montrose, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Montrose, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 215 | 21 CFR 640.3(b)(6) | Qualifications of donor - disease transmissible by blood |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 81 | 21 CFR 606.100(b)(2) | Donor qualifying tests & measurements |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |