FDA EIR - Yung Shin Pharmaceutical Industry Co., Ltd. - June 21, 2022

A Pre-Approval Inspection (PAI) of Yung Shin Pharmaceutical Industry Co., Ltd. in Tachia, Taichung, Taiwan, was conducted by the FDA from June 13-21, 2022. The inspection, focusing on the company's readiness for commercial manufacturing of a sterile injectable drug for the U.S. market, evaluated conformance to applications and data integrity under current Good Manufacturing Practices (21 CFR Part 211). The inspection concluded with five observations noted on an FDA Form 483. Key issues included the failure to adequately evaluate components for pyrogenic properties in exhibit batches and insufficient smoke studies to verify laminar airflow during aseptic filling. Furthermore, batch records lacked complete instructions for calculations and interventions, and equipment design was not always appropriate for its intended use. There was also a concern regarding the accuracy of data input from both computer and hard records, as these were not consistently checked. Additionally, the firm did not provide all requested deviation records until the very end of the inspection, which hindered a full assessment. The FDA's Center for Drug Evaluation and Research (CDER) will make the final compliance and pre-approval determination after the company addresses these significant deficiencies.