FDA 483 - Southwest Florida Fertility Center, P.A. - March 08, 2023

An FDA inspection of Southwest Florida Fertility Center, P.A. in Fort Myers, FL, a reproductive tissue establishment, revealed significant deficiencies in donor screening and eligibility procedures. The firm failed to adequately screen donors for communicable diseases, specifically Zika virus, and lacked proper procedures for HCT/P donor testing and eligibility determination, including for HIV-1, HBV, and HCV. One of these deficiencies was a repeat observation from a previous inspection.