FDA 483 - SpringCreek Fertility - August 02, 2021

SpringCreek Fertility, a reproductive tissue establishment in Centerville, OH, was cited for multiple deficiencies related to donor eligibility determination during an FDA inspection. Observations included failures in donor screening, untimely specimen collection for communicable disease testing, and inadequate record summaries and procedures for required tests. These issues indicate a lack of robust controls to ensure the safety and eligibility of HCT/P donors.