FDA 483 - American National Red Cross (The) - October 21, 2019

The American National Red Cross in Pleasant Hill, CA, a blood donor center, was cited for failing to establish indelible records documenting temperature controls during the inspection. Specifically, the firm did not record pre-conditioning start times for temperature-sensitive units as required by their SOPs, relying instead on erasable white boards. This indicates a significant lapse in maintaining proper documentation for critical process parameters.