EnGeneIC Pty Ltd. – FDA 483, Jun 18, 2026

EnGeneIC Pty Ltd., a sterile drug manufacturer in North Ryde, Australia, was cited for severe and systemic deficiencies across its manufacturing and quality control operations. The inspection revealed a complete lack of basic controls to assure sterility and quality, including unclassified environments, unvalidated processes, and repeated batch failures. The firm also lacked a functional Quality Unit and failed to maintain adequate records or investigate discrepancies.