FDA 483 - Fulijaya Manufacturing Sdn. Bhd - July 18, 2025

Fulijaya Manufacturing SDN. BHD. in Kulim, Kedah, Malaysia, was inspected regarding its drug product manufacturing. The inspection revealed significant deficiencies across its quality system, including inadequate stability programs, insufficient testing of raw materials and finished products for specifications and microorganisms, lack of validated cleaning procedures, and incomplete documentation for quality control and batch records. These issues indicate a systemic failure to ensure drug product quality and safety.