FDA 483 - Signature Biologics, LLC - December 16, 2021

An FDA inspection of Signature Biologics, LLC in Irving, TX, revealed significant deficiencies in the manufacturing of its injectable umbilical cord tissue and amniotic membrane derived products. The firm failed to adequately validate aseptic processes, perform endotoxin testing, investigate sterility failures, and establish proper production and process controls for its purported sterile drug products and HCT/Ps. These issues indicate a severe lack of quality control and process validation, potentially compromising product sterility and safety.