FDA Inspection 1079774 — Midwest Transplant Network
The FDA completed an inspection of Midwest Transplant Network on Feb 19, 2019 in Westwood, KS. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Westwood, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12382 | 21 CFR 1271.210(d)(3) | Lot documentation maintained |
| 12384 | 21 CFR 1271.215 | Potential problems with recovery |