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BioAsia Worldwide Sdn Bhd, a Malaysian drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pharmaceutical products. The company failed to conduct identity testing on individual drug components and did not validate the reliability of its component suppliers' test analyses at appropriate intervals, instead relying solely on suppliers' certificates of analysis without verification. The FDA determined that the firm's inadequate methods, facilities, and controls rendered its drug products adulterated, and rejected the company's November 2024 response as insufficient due to lack of supporting documentation and inadequate evidence of corrective actions.