Huahai Pharmaceutical (600521.SH) received a warning letter from the FDA involving pharmaceutical products at the Xunqiao production base

Zhitong Finance App News, Huahai Pharmaceutical (600521.SH) issued an announcement. The company recently received a warning letter from the US Food and Drug Administration (“FDA”). The warning letter is based on the FDA's on-site inspection of the company's pharmaceutical production base in Xunqiao Town, Linhai City (hereinafter referred to as “Xunqiao Production Base”) from January 16 to January 24, 2025. The warning letter put forward relevant inspection opinions and improvement suggestions for the formulation products at the Xunqiao production base, mainly relating to clean management of some oral solids production equipment, maintenance of sterile production areas, and sufficient research on tablet disposal parameters.

The company attaches great importance to the FDA's recommendations, has taken active steps to optimize it, and continues to maintain active communication with the FDA. The company will continue to improve its quality management system to ensure compliant operation. The company's formulation production bases mainly include the Xunqiao Formulation Production Base (located in Xunqiao Town, Linhai City, Zhejiang Province) and the subsidiary Zhejiang Huahai Pharmaceutical Technology Co., Ltd. (located in Jiangnan Street, Linhai City). This warning letter only has an impact on the approval of new ANDA applications or supplementary applications involving the Xunqiao production site, and will not have a significant impact on the company's current results.