# FDA 483 - Hendrick Regional Laboratory Transfusion Services - July 02, 2025

Source: https://www.globalkeysolutions.net/records/483/hendrick-regional-laboratory-transfusion-services/9187ffca-2a82-41a0-be80-66f4b93bcfd4

> FDA 483 for Hendrick Regional Laboratory Transfusion Services on July 02, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hendrick Regional Laboratory Transfusion Services
- Inspection Date: 2025-07-02
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of Hendrick Regional Laboratory Transfusion Services in Abilene, TX, from June 30 to July 2, 2025, revealed a significant deficiency. The firm failed to maintain complete reports of adverse reactions, specifically regarding an uncompleted investigation into a patient's transfusion reaction. This indicates a lapse in their quality system for tracking and investigating adverse events related to blood products.

## Related Documents

- [483 - 2022-03-10](https://www.globalkeysolutions.net/records/483/hendrick-regional-laboratory-transfusion-services/a2dde302-f9c4-44a1-b4d7-56b5c932fc5b)

## Related Officers

- [Michelle Paxon](https://www.globalkeysolutions.net/people/michelle-paxon/1748c593-7d85-4ede-a5f4-8c0a33c21d52)

Company: https://www.globalkeysolutions.net/companies/hendrick-regional-laboratory-transfusion-services/41436f32-683b-4b35-8f96-5bb4596046b3

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9