FDA 483 - Puerto Rico Fertility and Reproductive Center PSC - March 18, 2022

Puerto Rico Fertility and Reproductive Center PSC, a human tissue establishment in Bayamon, PR, was cited for significant deficiencies in its oocyte donor screening and testing processes. The inspection revealed that donors were not adequately screened for communicable disease risk factors, including ZIKV, and donor eligibility determinations were made before required communicable disease testing was completed or with improperly timed specimens. These issues indicate a serious lack of control over donor suitability, potentially compromising recipient safety.