FDA Inspection 598605 — Midwest Transplant Network
The FDA completed an inspection of Midwest Transplant Network on Jul 22, 2009 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 22, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Westwood, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12346 | 21 CFR 1271.190(b)(2) | Sewage, trash removal |
| 12384 | 21 CFR 1271.215 | Potential problems with recovery |