Novugen Pharma Sdn Bhd – FDA 483, Sep 7, 2022

An FDA inspection of Novugen Pharma Sdn Bhd, an oral solid dosage drug manufacturer in Bandar Baru Enstek, Malaysia, revealed significant deficiencies. Observations included inadequate procedures for cleaning validation and protection of clean equipment from contamination, lack of proper identification for major production equipment, and failures in documenting deviation report occurrence dates. These issues indicate a need for improved quality control and adherence to manufacturing standards.