# FDA 483 - Hendrick Regional Laboratory Transfusion Services - March 10, 2022

Source: https://www.globalkeysolutions.net/records/483/hendrick-regional-laboratory-transfusion-services/a2dde302-f9c4-44a1-b4d7-56b5c932fc5b

> FDA 483 for Hendrick Regional Laboratory Transfusion Services on March 10, 2022. 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: 2022-03-10
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Hendrick Regional Laboratory Transfusion Services in Abilene, TX, revealed a significant failure to report biological product deviations. The facility did not submit required reports within 45 days for multiple instances of erroneously issued or unrecorded blood products, including misidentified units and missing inventory. This indicates a serious lapse in regulatory compliance regarding blood product safety and tracking.

## Related Documents

- [483 - 2025-07-02](https://www.globalkeysolutions.net/records/483/hendrick-regional-laboratory-transfusion-services/9187ffca-2a82-41a0-be80-66f4b93bcfd4)

## Related Officers

- [Gloria A. Milster](https://www.globalkeysolutions.net/people/gloria-a-milster/22f95276-6f68-467d-8d52-5c028c118123)
- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab