FDA Inspection 697962 — Bloodworks
The FDA completed an inspection of Bloodworks on Nov 17, 2010 in Vancouver, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 17, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Vancouver, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |