# FDA 483 - HRF, Inc - July 27, 2021

Source: https://www.keypedia.com/records/483/hrf-inc/09b750fc-8202-4014-9cf9-81f50bb92772

> FDA 483 for HRF, Inc on July 27, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HRF, Inc
- Inspection Date: 2021-07-27
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of HRF, Inc. in Raleigh, NC, a source plasma donation center, revealed a significant deficiency in their donor screening process. The firm failed to conduct adequate medical history interviews, specifically not properly assessing risks for variable Creutzfeldt-Jakob disease and failing to include certain medications in their deferral list. This oversight impacts the safety and purity of collected blood and blood components.

## Related Documents

- [483 - 2019-03-20](https://www.keypedia.com/records/483/hrf-inc/53d46ff8-f3b0-4819-b08b-6b399581a25c)

## Related Officers

- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/hrf-inc/869e77e4-8d06-4ddb-890f-c1fe550ae080

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