FDA 483 - Hubei Meikai Chemical Co. Ltd - July 07, 2014

An FDA inspection of Hubei Meikai Chemical Co Ltd in Huanggang, P.R. China, an active pharmaceutical ingredient manufacturer, revealed significant deficiencies across its quality, laboratory, facility, and materials systems. The firm failed to adhere to its own procedures for internal audits and annual product reviews, and exhibited issues with laboratory controls, equipment calibration, and material identification. These observations indicate a lack of robust quality control and data integrity practices.