FDA 483 - Institute for Human Reproduction (IHR), SC - February 25, 2020

An FDA inspection of the Institute for Human Reproduction (IHR) in Chicago, IL, revealed significant deficiencies in donor screening practices for human reproductive cells and tissues. The firm failed to screen donors for Zika virus risk factors and lacked updated procedures for donor eligibility determination. Additionally, records did not properly document laboratory certification for communicable disease testing.