North Florida Reproductive Biology LaboratoryJune 28, 2019

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

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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