FDA 483 - Ohio Fertility Providers LLC - May 15, 2025
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An FDA inspection of Ohio Fertility Providers LLC in Cincinnati, OH, a human reproductive tissue facility, revealed two significant observations. The firm failed to quarantine HCT/Ps until donor-eligibility determinations were complete, resulting in the transfer of oocytes from a donor with an incomplete history. Additionally, HCT/Ps from donors with incomplete eligibility requirements were not prominently labeled with appropriate warning statements regarding communicable disease risk.
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ID · b163b6ff-44e6-4d04-8c43-13a5e72b6dfe