FDA EIR - Yung Shin Pharmaceutical Industry Co., Ltd. - June 21, 2021

The FDA conducted a pre-approval inspection of Yung Shin Pharmaceutical Industry Co., Ltd. (Taichung, Taiwan) from June 13-21, 2022. This inspection, guided by CPGMs 7346.832 for pre-approval inspections and 7356.002A for sterile drug process inspections, focused on assessing the firm's readiness for commercial manufacturing, conformance to applications, and data integrity for a sterile injection product. During the inspection, a five-item FDA Form 483 was issued. Key observations included: inadequate evaluation of components for pyrogenic properties in exhibit batches; insufficient smoke studies to verify laminar airflow during critical filling processes; incomplete instructions in batch records for calculations and interventions; equipment design not suitable for its intended use; and a lack of accuracy checks for data input from computer and hard records. The inspection also highlighted issues with not testing product contact primary packaging for pyrogens and inadequate air visualization studies to demonstrate unidirectional airflow control. Consequently, the FDA classified this inspection as Official Action Indicated (OAI), recommending an application withhold. This decision signifies that the firm is not deemed ready for commercial manufacturing of the Injection, mg/vial, due to the identified significant quality system deficiencies.