FDA 483 - Stony Brook Community Medical PC - Island Fertility - July 30, 2021

An FDA inspection of Stony Brook Community Medical PC - Island Fertility, a reproductive human tissue establishment, revealed significant deficiencies in donor eligibility determination. The firm failed to properly screen and test HCT/P donors for communicable diseases and infectious agents, and its procedures for donor eligibility were inadequate. Additionally, HCT/Ps that did not meet eligibility requirements were transferred to other facilities without proper warning labels.