FDA 483 - University Fertility Center - February 04, 2019
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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.
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