FDA EIR - American National Red Cross (CMMC) - February 13, 2023

This document summarizes three recent FDA inspections of American National Red Cross blood donor centers located in Auburn, Maine (February 13, 2023), Manchester, New Hampshire (July 28, 2022), and Milford, Connecticut (November 4, 2022). These preannounced inspections were conducted under the Office of Biological Products Operations (OBPO) workplans and Compliance Program 7342.001, which governs the inspection of blood banks and related facilities. The regulatory framework ensures the safety and quality of blood collection. Across all three sites, inspections covered donor eligibility, product collection, and quality assurance systems, including facility tours, observation of donor registration and screening, and review of operational records. Notably, none of these inspections resulted in an FDA Form 483, indicating no significant objectionable conditions. The Auburn, ME, site had one minor clerical error in a donor's apheresis history record, which was corrected immediately. The Manchester, NH, and Milford, CT, sites concluded with no discrepancies. No major violations were identified, and no specific regulatory actions were required by the FDA beyond the immediate correction of the minor recordkeeping issue. The overall findings reflect a high level of compliance at these American National Red Cross donor centers.