# FDA 483 - HRF, Inc - March 20, 2019

Source: https://www.keypedia.com/records/483/hrf-inc/53d46ff8-f3b0-4819-b08b-6b399581a25c

> FDA 483 for HRF, Inc on March 20, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: HRF, Inc
- Inspection Date: 2019-03-20
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of BRP, Inc, a source plasma donor center in Raleigh, NC, revealed significant deficiencies in donor screening and record-keeping practices. Observations included failures to correctly assess donor hematocrit values according to current regulations, lack of concurrent documentation for donor rechecks, and inadequate standard operating procedures for determining donor eligibility. These issues indicate a need for improved compliance with donor qualification and record-keeping requirements.

## Related Documents

- [483 - 2021-07-27](https://www.keypedia.com/records/483/hrf-inc/09b750fc-8202-4014-9cf9-81f50bb92772)

## 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