FDA 483 - Seattle Sperm Bank - June 12, 2025

An FDA inspection of Seattle Sperm Bank in Denver, CO, revealed two significant observations related to the handling of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from ineligible donors. The firm failed to properly label HCT/Ps from ineligible donors with biohazard warnings and communicable disease risk statements, and also did not include required summary records detailing donor eligibility determinations when shipping these products. These issues indicate deficiencies in the firm's procedures for ensuring the safety and proper documentation of HCT/Ps.