FDA 483 - Rejuvenating Fertility Center PLLC - October 25, 2024

An FDA inspection of Rejuvenating Fertility Center PLLC in Westport, CT, revealed significant deficiencies in their human reproductive tissue operations. The firm failed to establish adequate procedures for HCT/P donor screening and did not collect donor specimens for communicable disease testing at appropriate times. Additionally, donor eligibility determinations were made despite testing being performed outside required timeframes.