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Talk to a SpecialistTalk to a SpecialistKabana Skin Care LLC, a manufacturer of over-the-counter drugs including sunscreens and antibacterial hand sanitizers, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their finished drug products adulterated. During a February 2025 inspection, the FDA found the company failed to adequately test incoming components such as ethanol and glycerin for identity and conformity with written specifications, and failed to validate and establish the reliability of their component suppliers' test analyses at appropriate intervals as required by 21 CFR 211.84(d). The company's March 2025 response to the FDA's inspection findings was deemed inadequate due to lack of supportive documentation and insufficient evidence of corrective actions to achieve CGMP compliance.