FDA 483 - Southwest Florida Fertility Center, P.A. - March 14, 2019

Southwest Florida Fertility Center, P.A. in Fort Myers, FL, was inspected and cited for multiple deficiencies related to human cells, tissues, and cellular and tissue-based products (HCT/P) donor eligibility, screening, and testing. The inspection revealed a lack of documentation for donor eligibility determinations, inadequate communicable disease testing and screening, and deficient written operating procedures. Several observations were repeat deficiencies from previous inspections, indicating persistent issues with compliance.