By Fineline Cube 
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received a warning letter from the US Food and Drug Administration (FDA) following an on-site inspection of its Xunqiao Manufacturing Site in Xunqiao Town, Linhai City, conducted from January 16 to January 24, 2025.
FDA Observations and Recommendations
The FDA’s letter highlighted observations and improvement recommendations regarding drug products at the Xunqiao Manufacturing Site. Key areas of focus included cleaning management for certain oral solid manufacturing equipment, maintenance of sterile production areas, and the adequacy of parameter studies for tablet rejection during compression.
Company Response
Huahai Pharma stated that it takes the FDA’s feedback seriously and has already implemented proactive measures for optimization. The company is maintaining active communication with the FDA to address the concerns raised.
Impact of Warning Letter
The warning letter will affect the approval of new Abbreviated New Drug Application (ANDA) submissions or supplemental applications related to the Xunqiao Manufacturing Site. Huahai Pharma’s key manufacturing sites also include its subsidiary Zhejiang Huahai Pharmaceutical Technology Co., Ltd., located in Jiangnan Subdistrict, Linhai City.-Fineline Info & Tech