# FDA 483 - Ensign Laboratories Proprietary Ltd - July 15, 2022

Source: https://www.keypedia.com/records/483/ensign-laboratories-proprietary-ltd/327717b4-964e-485b-8be0-30a221b97c01

> FDA 483 for Ensign Laboratories Proprietary Ltd on July 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ensign Laboratories Proprietary Ltd
- Inspection Date: 2022-07-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ensign Laboratories Pty Ltd in Mulgrave, Australia, was inspected by the FDA from July 11-15, 2022, and received five observations. The inspection revealed significant deficiencies in quality control, including unapproved process and method validations, inadequate equipment qualification, and insufficient cleaning validation. These issues indicate a systemic failure to ensure drug product quality and purity.

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.keypedia.com/companies/ensign-laboratories-proprietary-ltd/a2609ae9-a810-4910-9ed6-71221b04abb7

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1