FDA Inspection 1086307 — LifeNet Health Northwest, LLC
The FDA completed an inspection of LifeNet Health Northwest, LLC on April 11, 2019 in Renton, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Renton, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12329 | 21 CFR 1271.160(d) | Documentation/approval prior to implementation |
| 12343 | 21 CFR 1271.190(a) | State of repair |
| 12345 | 21 CFR 1271.190(b)(1) | Clean, sanitary, orderly manner |
| 12349 | 21 CFR 1271.190(c) | Control system |
| 12426 | 21 CFR 1271.265(c)(2) | Improperly released for distribution |