# FDA 483 - Covenant Medical Center - April 08, 2022

Source: https://www.keypedia.com/records/483/covenant-medical-center/e04080b6-a11e-47b2-8920-2d5bca769ae1

> FDA 483 for Covenant Medical Center on April 08, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covenant Medical Center
- Inspection Date: 2022-04-08
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Covenant Medical Center, a blood bank in Lubbock, TX, was cited with two observations during an FDA inspection. The firm failed to establish adequate written procedures for HIV "lookback" notifications and experienced equipment failures related to temperature control for stored blood components. These issues indicate deficiencies in maintaining the safety and quality of blood products.

## Related Officers

- [Gloria A. Milster](https://www.keypedia.com/people/gloria-a-milster/22f95276-6f68-467d-8d52-5c028c118123)

Company: https://www.keypedia.com/companies/covenant-medical-center/9c1dbf46-2d1e-4310-b4c4-0a3215ad2b37

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