FDA 483 - Everlight Chemical Industrial Corporation Kuanyin II Plant

An FDA inspection of Everlight Chemical Industrial Corporation in Kuanyin Hsiang, Taiwan, from April 7-10, 2015, revealed significant data integrity and quality system deficiencies. The firm failed to properly investigate out-of-specification results, retain raw data, prevent unauthorized data changes, and document operations contemporaneously. Other serious issues included inadequate process validation, lack of endotoxin monitoring for injectable APIs, and insufficient quality unit oversight.