FDA 483 - INCELL Corporation LLC - September 29, 2023

INCELL Corporation LLC in San Antonio, TX, was inspected regarding its HCT/P manufacturing. The inspection revealed significant deficiencies in aseptic processing validation, quality control unit procedures, product testing, and stability data for its amniotic fluid-derived injectable products. These issues indicate a lack of robust controls to ensure product sterility, identity, and appropriate expiration dating.