FDA 483 - Polcz Fertility Lab, LLC - June 27, 2022

An FDA inspection of Polcz Fertility Lab, LLC in Boynton Beach, FL, a reproductive tissue establishment, revealed significant deficiencies in donor screening practices. The firm failed to adequately screen donors for communicable disease risk factors and lacked established written procedures for HCT/P donor screening. These issues indicate a potential risk to public health regarding the safety of donated tissues.