FDA 483 - American Red Cross Blood Services - May 06, 2026

The American National Red Cross, a donor center, received a Form 483 with four observations during an FDA inspection. The findings indicate significant issues with adherence to standard operating procedures for blood collection, failure to maintain complete records and conduct thorough non-conformance investigations, improper use of supplies contrary to manufacturer instructions, and inadequate storage conditions for platelets without proper temperature monitoring. These deficiencies suggest a need for improved quality system controls in their blood and blood component collection and processing operations.