Loading…
Fulijaya Manufacturing SDN. BHD., a Malaysian drug manufacturer, was found to be producing adulterated over-the-counter pharmaceuticals due to significant Current Good Manufacturing Practice (CGMP) violations. During a July 2025 inspection, the FDA identified critical failures in laboratory record-keeping, including the absence of complete raw data for microbiological release and stability testing, with the company unable to produce logbooks for tests conducted prior to May 2025. These deficiencies compromised data reliability and prevented the quality unit from verifying compliance with established specifications and standards as required by 21 CFR 211.194(a).