FDA 483 - EnGeneIC Pty Ltd. - December 20, 2026
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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.
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ID · 23c61c9b-279f-4670-a058-04a787a8e6bd