Catwalk Cosmetic Laboratories Pty Ltd. – FDA Warning Letter, Nov 21, 2024

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