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

Source: https://www.keypedia.com/records/483/ascension-via-christi-hospitals-wichita-inc/0f919ab4-11db-4dd7-89e7-7c98211870ca

> FDA 483 for Ascension Via Christi Hospitals Wichita Inc on November 18, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascension Via Christi Hospitals Wichita Inc
- Inspection Date: 2019-11-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Officers

- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)
- [Lee Terry Moore](https://www.keypedia.com/people/lee-terry-moore/eed5f225-7c3d-467a-8efb-7bb2e809c6b6)

Company: https://www.keypedia.com/companies/ascension-via-christi-hospitals-wichita-inc/86186950-8321-469d-b4ec-5032cf398546

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8
