483
Shady Grove FertilityFDA 483 - Shady Grove Fertility - October 11, 2019
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Shady Grove Fertility, a human tissue reproductive establishment in Arlington, VA, received a Form 483 with one observation. The inspection revealed a failure to establish and maintain adequate procedures for screening HCT/P donors. Specifically, the firm's policies and questionnaires lacked clear instructions for screening donors for Zika virus risk factors and clinical evidence of infection.
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ID · d7e96975-f1ec-440f-9539-ff51b2eb1e91