Kyungbo Pharmaceutical announced on the 18th that it passed an on-site manufacturing inspection by the U.S. Food and Drug Administration (FDA) and received a VAI (Voluntary Action Indicated) classification.
The inspection was conducted at Kyungbo Pharmaceutical’s Asan plant in Asan, South Chungcheong Province, and covered the manufacturing facilities producing active pharmaceutical ingredients (APIs) for products planned for commercialization in the United States: the fifth-generation cephalosporin antibiotic “Ceftobiprole” and the immunomodulatory anticancer agent “Lenalidomide.”
The FDA assessed the Asan plant’s compliance with U.S. current Good Manufacturing Practice (cGMP) across overall drug manufacturing operations, including manufacturing and process design, quality systems, and raw material management. The inspection identified certain items requiring improvement in the production process; however, because they were not deemed to have a significant impact on product quality, the FDA determined that no separate regulatory action was necessary and classified the Asan plant as VAI.
A Kyungbo Pharmaceutical official said, “A VAI classification means that the Asan plant’s overall management system meets cGMP standards,” adding, “Through proactive investment in facilities, we will further enhance the production environment and improve quality to strengthen our competitiveness in the global market.”
