FDA 483 - MAKRA KOZMETIKA D.O.O. - April 12, 2024

An FDA inspection of MAKRA KOZMETIKA D.O.O. in Kranj, Slovenia, revealed widespread and severe deficiencies across multiple systems for US market OTC drug products. The firm lacked fundamental laboratory controls, a functional quality control unit, adequate GMP training, proper equipment management, process validation, and robust material and labeling controls. These issues indicate a critical failure to adhere to Current Good Manufacturing Practice (cGMP) requirements, raising significant concerns about the quality, purity, and safety of their drug products.