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

Source: https://www.keypedia.com/records/483/cosmetic-manufacturers-aust-pty-ltd/5eacbdbd-8e96-4543-8bb8-00a6cf3d147e

> FDA 483 for Cosmetic Manufacturers (Aust) Pty Ltd. on April 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Manufacturers (Aust) Pty Ltd.
- Inspection Date: 2025-04-08
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2025-04-08](https://www.keypedia.com/records/warning_letter/cosmetic-manufacturers-aust-pty-ltd/8eaa15f2-5541-4b54-ad91-eb4704984624)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/cosmetic-manufacturers-aust-pty-ltd/11a13477-df71-482b-abd6-377253f5e945

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