FDA 483 - SHANGHAI GUAN SHENG YUAN FOOD LTD. FENGXIAN BRANCH - March 26, 2025

An FDA inspection of Shanghai Guan Sheng Yuan Food Ltd., Fengxian Branch, a milk candy manufacturer, revealed significant deficiencies across its food safety program. The firm failed to adequately identify hazards requiring preventive controls, including environmental pathogen recontamination and bacteria growth due to poor formulation, and lacked a robust supply chain program for raw materials. These issues indicate a serious lack of control over critical aspects of food production and safety.