483
Amicogen (China) Biopharm Co., Ltd.Amicogen (China) Biopharm Co., Ltd. – FDA 483, Mar 31, 2025
Record Details
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.
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ID · af80b3ff-0e36-4ea6-b51e-20d5de269d65
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