Huahai Pharmaceutical receives FDA warning letter

Zhejiang Huahai Pharmaceutical (SSE:600521) announced it received a warning letter from the U.S. Food and Drug Administration (FDA) following an inspection conducted between January 16 and January 24, 2025, at its Xunqiao production facility in Linhai City. The FDA's concerns primarily relate to the facility's management of equipment cleaning, maintenance of sterile production areas, and the parameters used for tablet rejection. Huahai Pharmaceutical stated it is taking the FDA's findings seriously and has already begun implementing corrective measures and plans to continue communication with the FDA. The company clarified that the warning letter only impacts pending ANDA approvals related to the Xunqiao production base and will not have a significant impact on the company's current financial performance.