FDA 483 - Massey Fertility Services - September 22, 2022

Massey Fertility Services, a reproductive HCT/P firm in Atlanta, GA, was cited for multiple deficiencies related to donor eligibility determination and record-keeping. The firm failed to properly screen donors for communicable disease risk factors, determined donors eligible despite reactive test results or physical evidence of risk, and did not maintain complete records of communicable disease testing. These issues indicate significant concerns regarding the safety and eligibility of donated HCT/Ps.