FDA EIR - Yung Shin Pharmaceutical Industry Co., Ltd. - October 22, 2019

The FDA conducted a routine Current Good Manufacturing Practice (CGMP) inspection of Yung Shin Pharmaceutical Industry Co., Ltd. from October 14 to October 22, 2019. This surveillance covered the manufacturing of human drug products and Active Pharmaceutical Ingredients (APIs), adhering to compliance programs for sterile drug processes, general drug manufacturing, and API production. The inspection resulted in a 7-item FDA-483, "Inspectional Observations." Key violations included a lack of adequate control procedures to monitor manufacturing process variability and ensure product consistency. The firm also failed to consistently follow written procedures for equipment cleaning and maintenance. Significant deficiencies were noted in procedures designed to prevent microbiological contamination for sterile drug products, alongside inadequate cleaning and disinfection systems in aseptic processing areas. Further issues involved insufficient laboratory controls to assure component and product quality, identity, and purity, as well as inadequate acceptance criteria for quality control unit testing and release. Finally, master production and control records were found to lack complete manufacturing and control instructions. The company's President and Vice-Chairman, Ms. Barbara Lee, acknowledged the observations and agreed to submit a written response to the FDA-483 within 15 working days. This response will be considered before any further regulatory actions are determined. The inspection was classified as Voluntary Action Indicated (VAI), with a recommendation for re-inspection based on CDER risk assessment.