FDA Inspection 793589 — Dept Of Veterans Affairs, Puget Sound Health Care System
The FDA completed an inspection of Dept Of Veterans Affairs, Puget Sound Health Care System on Aug 2, 2012 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 2, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 46 | 21 CFR 606.40(a)(6) | Provide space for quarantine of unsuitable for use items |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |