FDA 483 - Amicogen (China) Biopharm Co., Ltd. - March 31, 2025

Amicogen (China) Biopharm Co., Ltd. in Jining, China, received a Form 483 with three observations during an FDA inspection. The firm's sterile drug product manufacturing operations were found to be inadequately controlled, posing a risk of microbiological contamination due to issues with equipment, manual processes, and environmental controls. Additionally, the inspection revealed deficiencies in airflow visualization studies and incomplete batch production and control records.