FDA WARNING_LETTER - Kabana Skin Care - February 20, 2025

Kabana Skin Care LLC, located at 685 S Arthur Ave Unit 9b, Louisville, CO, was inspected by the FDA from February 19 to 20, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in Title 21 CFR parts 210 and 211. The FDA identified that Kabana Skin Care LLC"s drug products are adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Key violations include the failure to test samples of each component for identity and conformity with specifications for purity, strength, and quality. Specifically, the company did not adequately test high-risk components like ethanol and glycerin for hazardous impurities such as methanol, diethylene glycol (DEG), and ethylene glycol (EG). Additionally, Kabana Skin Care LLC did not perform appropriate laboratory testing for each batch of drug products before release, nor did they ensure their quality control unit maintained compliance with CGMP standards.

In response to these findings, Kabana Skin Care LLC committed to ceasing the manufacturing and distribution of all drugs for the U.S. market and agreed to a voluntary recall of all drugs currently in distribution. The company has also deregistered its facility as a drug manufacturer. If Kabana Skin Care LLC intends to resume drug manufacturing, they must notify the FDA and engage a qualified consultant to ensure compliance with CGMP requirements. The company is also reminded that any cosmetics they manufacture must comply with applicable statutory and regulatory requirements, including the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Failure to address these violations promptly may result in regulatory or legal action, including seizure, injunction, or withholding of Export Certificates.