FDA 483 - Fairfax Cryobank Inc - Fairfax - August 24, 2023

Fairfax Cryobank, Inc. in Fairfax, VA, was cited for distributing semen specimens from donors with incomplete Zika virus (ZIKV) screening before obtaining necessary exemptions or alternatives. This practice occurred over several years, despite repeated FDA instructions to quarantine such specimens until an exemption was granted. The firm distributed HCT/Ps that were not fully screened and released them without proper authorization.