Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. received a warning letter from the FDA based on an inspection conducted from January 16 to January 24, 2025, at its production facility in Xunqiao Town, Linhai City, which raised concerns regarding the management of cleaning for solid oral production equipment, maintenance of sterile production areas, and the adequacy of parameters for tablet rejection studies [1][2]. Group 1 - The warning letter specifically affects the approval of ANDA new applications or supplemental applications related to the Xunqiao production facility, but it will not have a significant impact on the company's current performance [2]. - The company is taking the FDA's suggestions seriously and has begun to implement optimization measures while maintaining active communication with the FDA [1][2]. - The company is committed to continuously improving its quality management system to ensure compliance with operational standards [1].