483
Global Premier Fertility Orange County LLCFDA 483 - Global Premier Fertility Orange County LLC - April 11, 2025
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An FDA inspection of Global Premier Fertility Orange County LLC, a human reproductive tissue establishment, identified three observations related to donor record management. The firm failed to adequately protect donor anonymity, document communicable disease testing certification, and maintain complete donor eligibility determinations. These deficiencies indicate significant issues in the firm's compliance with HCT/P regulations.
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ID · 210bea8f-ac7d-4d04-85bb-87448c8560b8