FDA 483 - fmg Co., Ltd. - July 25, 2025

fmg Co., Ltd. in Chuncheon, Korea, received a Form 483 with six observations related to significant deficiencies in its quality control unit and manufacturing processes. The inspection revealed failures in investigating out-of-event incidents, lack of written procedures for testing and audit trails, inadequate employee training, and insufficient microbiological testing for objectionable organisms. Additionally, the firm's cleaning validation and raw material sampling procedures were found to be deficient, indicating a systemic breakdown in ensuring drug product quality and safety.