# FDA 483 - Mission Hospitals Transfusion Service - May 15, 2025

Source: https://www.keypedia.com/records/483/mission-hospitals-transfusion-service/53e89699-d8f7-45f9-aec8-b8ed333bf6e0

> FDA 483 for Mission Hospitals Transfusion Service on May 15, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mission Hospitals Transfusion Service
- Inspection Date: 2025-05-15
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Mission Hospitals Transfusion Service in Asheville, NC, revealed that the firm failed to consistently follow its written standard operating procedures for processing and distributing blood and blood components. Specifically, procedures for neonatal transfusion aliquot preparation were not adhered to, resulting in improper handling and dispensing of an RBC neonatal aliquot. This indicates a significant lapse in procedural compliance within the hospital's transfusion service.

## Related Officers

- [investigator](https://www.keypedia.com/people/randy-l-clarida/aae3cc15-a908-4489-9299-7542370ad3cd)

Company: https://www.keypedia.com/companies/mission-hospitals-transfusion-service/83ed297f-a2fd-4b51-b351-0c03e148bbc7

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7