FDA 483 - University Fertility Center - February 04, 2019

University Fertility Center in Torrance, CA, received a Form 483 following an inspection related to human reproductive tissue. The inspection revealed significant deficiencies in donor screening and testing procedures for communicable disease agents, including inadequate questionnaires and a lack of required West Nile Virus testing for several oocyte donors. Additionally, the firm's procedures for determining donor eligibility were not adequately defined or implemented.