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

During an FDA inspection conducted from February 24 to March 3, 2025, Zhejiang Guobang Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient manufacturer in Shaoxing, P.R. China, received a Form 483 observation. The primary issue cited was a lack of scientifically justified and appropriate laboratory controls for testing water utilized in critical equipment cleaning for drug substance manufacturing. Specifically, the company's microbial monitoring of process water was found deficient. The FDA noted inadequate sample sizes for testing, insufficient sampling locations for statistically valid microbial counts, and a failure to validate sampling methods to ensure comprehensive capture of microbial colonies. Furthermore, the firm did not adequately detect and enumerate microorganisms from potential biofilms in their water system, nor did their method validation studies incorporate typical 'house isolates' due to a lack of microbiome identification. The water specification itself was deemed not scientifically justified to exclude objectionable microorganisms, and the company failed to speciate microbial recoveries to identify potential pathogens. These observations indicate a failure to adhere to Current Good Manufacturing Practices (cGMP) related to quality control for manufacturing active pharmaceutical ingredients. To address these issues, Zhejiang Guobang Pharmaceutical Co., Ltd. must implement robust and scientifically sound laboratory controls, including validated sampling procedures, comprehensive microbial detection methods, and justified water quality specifications to ensure product purity and patient safety.