FDA 483 - American Red Cross National Headquarters - May 19, 2014

The American National Red Cross, Biomedical Services, in Washington, D.C., was cited for multiple significant deficiencies during an FDA inspection. These issues include inadequate validation of its ePROGESA computer system, ineffective quarantine procedures leading to the reissuance of unsuitable blood products, and failures in distribution traceability. Additionally, the firm did not conduct thorough investigations, submit timely biological product deviation reports, maintain concurrent records, or comply with specific paragraphs of a consent decree regarding notifications and document provision.