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483
•North Florida Reproductive Biology Laboratory•June 28, 2019

FDA 483 - North Florida Reproductive Biology Laboratory - June 28, 2019

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Record Details

An FDA inspection of North Florida Reproductive Biology Laboratory in Jacksonville, FL, a human reproductive tissue establishment, identified one observation. The firm failed to adequately screen oocyte donors for disease risks related to xenotransplantation. This indicates a lapse in donor eligibility determination processes.

Company
North Florida Reproductive Biology Laboratory
Inspection Date
June 28, 2019
Product Type
Biologics
Office
Office of Medical Device and Radiological Health Division II
People
  • Julie D. Bringger (Director)
  • Valerie J. Grecek Trinh (Investigator)
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ID · ce4d9582-a93f-4f2d-8005-2924494032dc

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