FDA 483 - Cryos International USA LLC - March 22, 2024

Cryos International USA LLC, a reproductive tissue establishment in Raleigh, NC, was cited for failing to quarantine HCT/Ps (Human Cells, Tissues, and Cellular and Tissue-Based Products) during shipment prior to completing donor eligibility determinations. The firm's manual incorrectly stated that anonymous oocyte donors are not required to be quarantined, leading to multiple instances where oocytes were shipped without proper quarantine identification while donor eligibility was still pending. This indicates a significant lapse in adherence to regulatory requirements for tissue handling and donor screening.