FDA 483 - Fairfax Cryobank Inc - Fairfax - March 20, 2019

An FDA inspection of Fairfax Cryobank, Inc. in Fairfax, VA, a human reproductive tissue establishment, revealed significant deficiencies in donor eligibility processes. Observations included a failure to maintain complete documentation for donor eligibility determinations, inadequate screening of semen donors for communicable disease risks like Zika virus, and a lack of established procedures for determining donor eligibility. These issues indicate a need for improved controls in donor screening and record-keeping.