FDA 483 - American National Red Cross (The) - July 31, 2025

The American National Red Cross in Modesto, CA, was inspected from July 28-31, 2025, revealing a critical failure in the proper storage of platelets. Specifically, the facility lacked equipment for continuous gentle agitation of platelets after resuspension, leading to units being stored for extended periods without meeting required conditions. This indicates a significant deviation from established storage protocols for blood components.