American Red Cross Blood SvcsOctober 16, 2023

FDA 483 - American Red Cross Blood Svcs - October 16, 2023

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Record Details

An FDA inspection of American Red Cross Blood Svcs in Durham, NC, identified a significant issue regarding data integrity. The firm failed to ensure backup data was exact, complete, and secure, specifically noting an unvalidated blood establishment computer system used in their immunology reference laboratory. This raises concerns about the reliability of patient testing data.

Company: American Red Cross Blood Svcs
Inspection Date: October 16, 2023
Product Type: Biologics
Office: Atlanta District Office
People: Steven D. Banks
Marla A. Cassidy

Open in Dashboard

ID · 2a8f1d5e-d851-4821-abd1-a1c32a5c7d32