483
Northeastern Reproductive Medicine PLLCNortheastern Reproductive Medicine PLLC – FDA 483, Aug 16, 2019
Record Details
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.
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ID · dc83ec30-69a8-4e65-9022-8cbdacc5d017
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