FDA 483 - Hugel Inc. - August 20, 2021

Hugel, Inc. in Chuncheon, Gangwon, Korea, was inspected for drug substance and drug product manufacturing. The inspection revealed significant issues related to Clostridium botulinum spore control, including inadequate containment, decontamination, and environmental monitoring. Additionally, the firm had deficiencies in OOS investigations, logbook management, cell bank comparability, and batch filling time controls.