Catwalk Cosmetic Laboratories Gets a Warning Letter from the US FDA

Catwalk Cosmetic Laboratories Pty Ltd., Muizenberg Western Cape, South Africa, received a Warning Letter from the US Food and Drug Administration on Nov. 21, 2024. According to the FDA, the company’s manufacturing facility in South Africa violates several Current Good Manufacturing Practices (CGMP).

These violations include:

• Failure to conduct at least one test to verify the identity of each component of a drug product.

• Failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient before release.

• Failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use stability testing results to determine the appropriate storage conditions and expiration dates.

• Failure to establish written procedures for production and process control designed to assure that the manufactured drug products have the identity, strength, quality and purity they purport or are represented to possess.

• Failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling and drug products.