Huahai Pharmaceutical announced that the company recently received a warning letter from the US Food and Drug Administration. The warning letter was based on the FDA's on-site inspection of the company's pharmaceutical production base in Xunqiao Town, Linhai City 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. 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.

Zhitongcaijing · 06/09 10:01
Huahai Pharmaceutical announced that the company recently received a warning letter from the US Food and Drug Administration. The warning letter was based on the FDA's on-site inspection of the company's pharmaceutical production base in Xunqiao Town, Linhai City 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. 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.