FDA 483 - Zhejiang Ruibang Laboratories Co., Ltd - July 21, 2016

An FDA inspection of Zhejiang Ruibang Laboratories, an API manufacturer in Wenzhou, China, revealed significant deficiencies in their quality control systems. Observations included failures in computerized system data integrity, lack of scientifically sound sampling plans for materials, and inadequate investigation and documentation of deviations. These issues indicate a concerning lack of control over critical manufacturing and quality processes.