FDA 483 - California Cryobank, LLC - February 27, 2025

During an inspection, California Cryobank, LLC, a reproductive firm in Los Altos, CA, received one observation. The firm was cited for shipping anonymous semen vials, classified as HCT/Ps, while they were still in quarantine and awaiting donor eligibility determinations. These shipments lacked the required accompanying records indicating that donor eligibility had not yet been completed.