# FDA WARNING_LETTER - Catwalk Cosmetic Laboratories Pty Ltd. - November 21, 2024

Source: https://www.keypedia.com/records/warning_letter/catwalk-cosmetic-laboratories-pty-ltd/fbcc69cd-e522-4c55-9618-8c7c638ae6a1

> FDA WARNING_LETTER for Catwalk Cosmetic Laboratories Pty Ltd. on November 21, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Catwalk Cosmetic Laboratories Pty Ltd.
- Inspection Date: 2024-11-21
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Catwalk Cosmetic Laboratories Pty Ltd. on November 21, 2024, following a review of records submitted on March 25, 2024, under section 704(a)(4) of the FD&C Act. The facility, registered as an OTC drug manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated.

Key violations include:
1.  **Failure to identity test components (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming components, such as (b)(4), for identity, including (b)(4) and (b)(4) limit testing, which are critical for safety.
2.  **Inadequate finished product testing (21 CFR 211.165(a)):** Only pH, viscosity, and organoleptic comparison were performed, lacking full release testing, including active ingredient strength and identity.
3.  **No adequate stability testing program (21 CFR 211.166(a)):** Potency and assay testing were not part of the stability program, failing to support product shelf life.
4.  **Lack of process validation (21 CFR 211.100(a)):** The firm lacked written procedures and studies for process validation, failing

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [David Lennarz](https://www.keypedia.com/people/david-lennarz/7524fe46-01da-49a0-b6c1-45210bf91809)

Company: https://www.keypedia.com/companies/catwalk-cosmetic-laboratories-pty-ltd/8c365473-2b1e-45a3-9d62-b6fbbeb79c32

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c