FDA 483 - HRC Fertility - May 24, 2023

An FDA inspection of HRC Fertility, a human tissue reproductive establishment in Carlsbad, CA, identified one observation. The firm failed to adequately screen donors for communicable disease risk factors, specifically regarding West Nile Virus (WNV) infection. This was due to a donor screening questionnaire that did not solicit information about recent WNV NAT test results.