FDA 483 - Michigan Reproductive and IVF Center, PLLC - April 27, 2023

An FDA inspection of Michigan Reproductive and IVF Center, PLLC in Grand Rapids, MI, revealed significant deficiencies in donor screening practices for reproductive human tissue. The firm failed to adequately screen oocyte and semen donors for communicable disease agents, specifically by omitting physical examinations of the pelvic and reproductive organ areas. Additionally, the firm deemed a donor eligible despite an incomplete screening history and a reactive Hepatitis B test, indicating a failure to properly assess donor eligibility.