FDA 483 - Ascension Via Christi Hospitals Wichita Inc - November 18, 2019
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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
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