FDA 483 - Zhejiang Guobang Pharmaceutical Co., Ltd - March 03, 2025

An FDA inspection of Zhejiang Guobang Pharmaceutical Co., Ltd. revealed significant deficiencies in laboratory controls related to their water systems used in drug substance manufacturing. The firm lacked scientifically justified specifications and test procedures for (b)(4) water, failing to ensure its identity, quality, and purity. This included inadequate microbial monitoring, failure to detect potential biofilms, and insufficient speciation of microorganisms in their water system.