FDA Inspection 1110377 — Ascension Via Christi Hospitals Wichita Inc
The FDA completed an inspection of Ascension Via Christi Hospitals Wichita Inc on November 18, 2019 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
- November 18, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wichita, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9225 | 21 CFR 606.171 | Biological product deviation report |