FDA 483 - Innovative Fertility Center - December 17, 2024

Innovative Fertility Center in Manhattan Beach, CA, received a Form 483 following an inspection that identified deficiencies in their HCT/P donor screening processes. The firm failed to adequately screen donors for all required communicable disease agents, such as West Nile Virus and xenotransplantation, and did not maintain proper screening procedures. Additionally, the establishment's address was missing from donor eligibility determination records.