FDA 483 - The Cryo Laboratory of EVMS - Jones Institute - July 25, 2019

An FDA inspection of The Cryo Laboratory of EVMS - Jones Institute in Norfolk, VA, a reproductive facility, identified a significant issue regarding donor screening. The firm failed to test reproductive donors for relevant communicable disease agents, specifically West Nile Virus, during the designated WNV season. This lapse in testing affected directed and anonymous semen donors.