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

Source: https://www.keypedia.com/records/483/mission-hospitals-transfusion-service/8c98c33e-887f-47dc-9a1b-cfb786ca0f93

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

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## Details

- Record Type: 483
- Company Name: Mission Hospitals Transfusion Service
- Inspection Date: 2025-05-15
- Product Type: biologics
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: Mission Hospitals Transfusion Service in Asheville, NC, was inspected by the FDA, revealing a significant procedural non-compliance. The firm failed to consistently follow its written standard operating procedures for the processing and distribution of blood and blood components, specifically concerning neonatal transfusion aliquot preparation and timing. This indicates a lapse in adherence to established protocols for critical patient care.

## Related Documents

- [483 - 2025-05-15](https://www.keypedia.com/records/483/mission-hospitals-transfusion-service/53e89699-d8f7-45f9-aec8-b8ed333bf6e0)

## 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/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43