FDA 483 - Florida Fertility Institute, P.A. - February 02, 2023

An FDA inspection of Florida Fertility Institute, P.A. in Clearwater, FL, a reproductive tissue establishment, revealed significant deficiencies in donor eligibility determination, screening, and labeling practices. The firm failed to properly document donor eligibility, made eligibility determinations before receiving communicable disease test results, and included identifying personal information in anonymous donor records. Additionally, there were issues with inadequate donor screening, improper labeling of HCT/Ps from ineligible or exempt donors, and deficient standard operating procedures for donor testing, screening, and labeling.