FDA 483 - Kabana Skin Care - February 20, 2025

KABANA SKIN CARE, an OTC manufacturer in Louisville, CO, was cited with seven observations during an FDA inspection. The firm demonstrated a severe lack of fundamental quality control systems, including the absence of a quality control unit, inadequate written procedures for manufacturing and testing, and a failure to validate processes and equipment. These deficiencies indicate significant non-compliance with cGMP regulations, impacting product identity, strength, quality, and purity.