FDA Inspection 897356 — HealthOne Swedish Medical Center Blood Bank
The FDA completed an inspection of HealthOne Swedish Medical Center Blood Bank on Sep 22, 2014 in Englewood, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 22, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |