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

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.