FDA Inspection 1256234 — Wesley Medical Center
The FDA completed an inspection of Wesley Medical Center on December 10, 2024 in Wichita, KS. 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
- December 10, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wichita, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 15044 | 21 CFR 610.47(b)(3) | Notify Transfusion Recipients or MD of Record [Consignee] |
| 15075 | 21 CFR 610.46(b)(3) | Notify Transfusion Recips or MD of Record [Consignee] |