FDA Inspection 831089 — LifeNet Health Northwest, LLC
The FDA completed an inspection of LifeNet Health Northwest, LLC on May 8, 2013 in Renton, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 8, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Renton, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12390 | 21 CFR 1271.220(c) | In-process HCT/Ps-control |