FDA 483 - Cryos International USA, LLC - March 08, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 0fe555bf-6645-4aa7-94c8-4f30c6a150ba