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

An FDA inspection of Zhejiang Huayi Pharmaceutical Co., Ltd. from April 14-18, 2025, identified significant deficiencies in the company's manufacturing and quality control processes for active pharmaceutical ingredients (APIs). The FDA Form 483 issued to the API manufacturer highlighted several areas requiring immediate corrective action to ensure compliance with quality standards. A primary concern was the inadequate cleaning and maintenance of equipment, with inspectors finding residue on production equipment despite documented cleaning, indicating a lack of effective oversight to prevent contamination. This included visible residue inside equipment and on surfaces in clean areas. Furthermore, the facility demonstrated a failure in maintaining appropriate storage conditions for raw materials. The raw material warehouse exhibited extreme temperature fluctuations, ranging from 0-3 degrees Celsius to 37 degrees Celsius, which could compromise material quality. Finally, the inspection revealed deficiencies in quality control testing procedures, specifically the use of unvalidated and unverified naked-eye examination of microbial culture media plates under ambient light. These observations necessitate comprehensive corrective measures from Zhejiang Huayi Pharmaceutical Co., Ltd. to address equipment sanitation, environmental control, and scientific validation of testing procedures to meet regulatory expectations.