483
EversightEversight – FDA 483, Feb 19, 2019
Record Details
An FDA inspection of Eversight, a human tissue establishment in Clark, NJ, revealed two significant observations related to donor eligibility. The firm failed to ensure that a responsible person properly determined and documented HCT/P donor eligibility based on screening and testing results. Additionally, HCT/Ps were not accompanied by a statement indicating the donor's eligibility status after the determination was completed.
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ID · c093cb3e-6f5b-4baa-8f7d-c742778aa876
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