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

Fairfax Cryobank, Inc., a Human Reproductive Tissue Establishment, was inspected by the FDA from March 13-20, 2019. The inspection, conducted under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlighted several critical compliance issues. Main violations included the failure to maintain proper documentation of donor eligibility determinations for anonymous semen donors, including the responsible individual and dates, an issue dating back to May 2005. Furthermore, the company's screening processes for communicable disease agents and diseases were found to be inadequate. Specifically, donors were not consistently screened for Zika Virus transmission risk between May 2016 and November 2018, nor for a specific infection using an FDA-licensed method from 2007 to present, and another condition for directed semen donors since December 2018. Lastly, the firm lacked established and maintained standard operating procedures detailing all steps for determining anonymous semen donor eligibility. Fairfax Cryobank, Inc. is required to review these observations, implement comprehensive corrective actions, and may need to submit these plans to the FDA to address the identified deficiencies and ensure regulatory compliance.