FDA 483 - Hangzhou Linkeweier Daily Chemicals Co., Ltd. - September 17, 2019

An FDA inspection of Hangzhou Linkeweier Daily Chemicals Co. Ltd. in Hangzhou, Zhejiang, revealed significant deficiencies across its quality, laboratory, material, production, and facilities systems. The firm, a finished drug product manufacturer, failed to establish and follow numerous written procedures, specifications, and testing programs essential for ensuring the identity, strength, quality, and purity of its OTC drug products. These widespread issues indicate a serious lack of control over critical manufacturing and quality processes.