FDA 483 - Specialists in Reproductive Medicine & Surgery, P.A. - April 15, 2022

An FDA inspection of Specialists in Reproductive Medicine & Surgery, P.A. in Fort Myers, FL, revealed significant deficiencies in their donor screening and testing procedures for reproductive tissues. Observations included improper timing of communicable disease agent testing for donor specimens, inadequate screening of donors for communicable disease risk factors, and a lack of established procedures for screening and testing HCT/P donors for specific viruses like Zika and West Nile. This indicates a need for improved controls to ensure donor eligibility and product safety.