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Janssen Vaccines Corp.'s drug manufacturing facility in South Korea was found to have violated Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in November 2024. The company failed to conduct adequate investigations of recurring complaints regarding stopper defects associated with injection products between November 2023 and November 2024, including instances where multiple vials from the same batch were affected, and did not identify relevant quality issues that could have caused the observed defects. These manufacturing control failures rendered the drug products adulterated under federal law, as the firm's methods, facilities, and controls did not conform to CGMP standards.