Southwest Florida Fertility Center, P.A. – FDA 483, Mar 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.
ID · d81073bc-c691-4f9b-a819-7384e2eca80a
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.