# FDA 483 - EnGeneIC Pty Ltd. - December 20, 2026

Source: https://www.keypedia.com/records/483/engeneic-pty-ltd/23c61c9b-279f-4670-a058-04a787a8e6bd

> FDA 483 for EnGeneIC Pty Ltd. on December 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EnGeneIC Pty Ltd.
- Inspection Date: 2026-12-20
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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.

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/engeneic-pty-ltd/85e4ea7c-714e-448f-becd-c47b39772192

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3