FDA 483 - Hangzhou Huadong Medicine Group Zhejiang Huayi Pharmaceutical Co., LTD. - April 18, 2025

Zhejiang Huayi Pharmaceutical Co., Ltd., an API manufacturer in Yiwu, China, was cited for three observations during an FDA inspection. The observations include failures in equipment cleaning, inadequate temperature control for material storage, and the use of unvalidated test procedures for examining microbial culture media plates. These issues indicate a lack of sufficient oversight and control over critical manufacturing and quality processes.