FDA 483 - Cryos International USA, LLC - March 08, 2022

Cryos International USA, LLC, a reproductive tissue establishment in Orlando, FL, was cited for multiple deficiencies related to donor screening and testing for communicable disease agents. Observations included failures in initial and retesting for diseases like West Nile Virus, inadequate donor screening questionnaires with incorrect timeframes and missing risk factors, and the use of abbreviated screening procedures. The firm also lacked comprehensive written procedures for HCT/P donor screening.