Ascension Via Christi Hospitals Wichita Inc – FDA 483, Nov 18, 2019
An FDA inspection of VIA Christi Regional Med Cntr's unlicensed blood bank in Wichita, KS, revealed significant deficiencies. The facility failed to adequately review blood product irradiation records before release and did not consistently follow its own standard operating procedures for blood component processing. Furthermore, the firm neglected to submit required biological product deviation reports for several critical events, indicating a serious lapse in regulatory compliance and patient safety protocols.
- Inspection date
- November 18, 2019
- Product type
- biologics
ID · 0f919ab4-11db-4dd7-89e7-7c98211870ca
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.