FDA Inspection 1151318 — Tacoma-Pierce County Blood Bank
The FDA completed an inspection of Tacoma-Pierce County Blood Bank on Sep 9, 2021 in Tacoma, 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 9, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tacoma, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 155 | 21 CFR 606.160(b) | Required records |
| 18068 | 21 CFR 630.5(d) | CPR certification |
| 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 |
| 98 | 21 CFR 606.100(c) | Thorough investigations |