FDA 483 - Re-Gen Active Lab Inc - July 28, 2021

Re-Gen Active Lab Inc. in Irving, TX, a stem cell manufacturer, was cited for 11 significant violations during an FDA inspection. The firm failed to establish and follow critical procedures for aseptic processing, environmental monitoring, process validation, component control, cleaning, equipment control, batch records, donor eligibility, stability testing, and employee training. These deficiencies pose substantial risks to the sterility and quality of their injectable products derived from human umbilical cord tissue and amniotic membrane.