FDA Inspection 1146276 — Bloodworks
The FDA completed an inspection of Bloodworks on Jul 16, 2021 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 16, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |