FDA 483 - Poma Fertility, LLC - June 19, 2019

An FDA inspection of Poma Fertility, LLC, a human reproductive tissue establishment in Kirkland, WA, revealed significant deficiencies in their donor eligibility determination processes. The firm failed to adequately screen and test HCT/P donors for communicable disease agents, including West Nile Virus and Zika, and did not properly evaluate risk factors like recent tattooing. Furthermore, the inspection found a lack of established, defined, and documented procedures for donor testing, screening, and eligibility determinations.