FDA 483 - Hugel Inc. - March 10, 2023

Hugel, Inc. (Site 2) in Chuncheon-si, Republic of Korea, was inspected for its drug substance and drug product manufacturing facilities. The inspection revealed significant deficiencies across multiple areas, including inadequate cleaning and disinfection programs, compromised laboratory data integrity, and critical failures in aseptic processing and environmental monitoring. The firm's quality unit oversight was also found to be insufficient, indicating a broad lack of control over GMP operations.