FDA 483 - Northeastern Reproductive Medicine PLLC - August 16, 2019

Northeastern Reproductive Medicine PLLC in Colchester, VT, a reproductive HCT/P establishment, was cited for two observations related to donor screening. The firm failed to adequately screen donors for communicable disease agents, including Zika virus (ZIKV), and lacked defined procedures for donor eligibility determination. This indicates deficiencies in their donor screening processes and associated documentation.