FDA EIR - Everlight Chemical Industrial Corporation Kuanyin II Plant - April 10, 2015

An FDA surveillance Good Manufacturing Practice (GMP) inspection was conducted at Everlight Chemical Industrial Corporation, an active pharmaceutical ingredient (API) manufacturer in Taoyuan Hsien, Taiwan, from April 7 to April 10, 2015. The inspection, guided by compliance program 7356.002F and ICH Q7, evaluated the company's Quality, Facilities and Equipment, Production, and Laboratory systems. The firm manufactures non-sterile API products for human drug products distributed in the US market.The inspection identified significant deviations, resulting in a 12-item FDA Form 483. Key violations included systemic failures in investigating non-conforming analytical data, inadequate data evaluation for product specifications, and poor documentation practices for analytical and production operations. The firm also failed to protect electronic raw data, monitor for endotoxin, and ensure robust process control through validation. Critical quality unit oversight was lacking, with production documents not reviewed prior to product release. Furthermore, the inspection noted a failure to support product stability with adequate data and an issue with hand washing facilities. A verbal observation highlighted the company's insufficient understanding of its supply chain, particularly regarding US market distribution. Importantly, several issues from a previous 2012 inspection persisted.Everlight Chemical Industrial Corporation's management committed to addressing all observations and providing a written response within 15 business days. The FDA classified the inspection as Official Action Indicated (OAI), signifying serious non-compliance requiring further regulatory action.