FDA 483 - Eversight - February 19, 2019

An FDA inspection of Eversight, a human tissue establishment in Clark, NJ, revealed two significant observations related to donor eligibility. The firm failed to ensure that a responsible person properly determined and documented HCT/P donor eligibility based on screening and testing results. Additionally, HCT/Ps were not accompanied by a statement indicating the donor's eligibility status after the determination was completed.