FDA Inspection 745191 — Bloodworks
The FDA completed an inspection of Bloodworks on Sep 7, 2011 in Seattle, WA. 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). 8 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 7, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 157 | 21 CFR 606.160(d) | Retention period |
| 215 | 21 CFR 640.3(b)(6) | Qualifications of donor - disease transmissible by blood |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 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 |
| 98 | 21 CFR 606.100(c) | Thorough investigations |