# FDA 483 - American Red Cross Blood Svcs - March 19, 2026

Source: https://www.keypedia.com/records/483/american-red-cross-blood-svcs/ce67a869-200b-4792-b1b6-2d726504fcd9

> FDA 483 for American Red Cross Blood Svcs on March 19, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: American Red Cross Blood Svcs
- Inspection Date: 2026-03-19
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: The FDA inspected American Red Cross Blood Svcs in Durham, NC, and identified a significant deficiency related to computer system validation. The firm failed to maintain written records and appropriate validation data for its blood establishment computer system, which is used for critical immunology reference laboratory functions. This indicates a serious lapse in quality control and data integrity for blood product testing.

## Related Documents

- [483 - 2023-10-16](https://www.keypedia.com/records/483/american-red-cross-blood-svcs/2a8f1d5e-d851-4821-abd1-a1c32a5c7d32)

## Related Officers

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

Company: https://www.keypedia.com/companies/american-red-cross-blood-svcs/dbc004ef-d184-4e65-8bcd-71f7c1f9cd64

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