FDA 483 - Cosmetic Manufacturers (Aust) Pty Ltd. - April 08, 2025

An FDA inspection of Cosmetic Manufacturers (Aust) Pty Ltd. in Helensvale, Australia, revealed significant deficiencies across multiple areas of their drug product manufacturing operations. The firm failed to establish adequate production and process controls, including validation studies and comprehensive quality unit testing. Additionally, issues were identified with equipment qualification, cleaning validation, insufficient laboratory controls for component and product testing, and a critical failure to investigate yield discrepancies for drug product batches.