Jiangsu Hengrui Medicine (SHA: 600276), a prominent player in China’s pharmaceutical industry, has received a warning letter from the US Food and Drug Administration (FDA), following a Form 483 issued earlier this year in June. The FDA’s notice highlights two principal deficiencies at Hengrui’s facility: the company’s quality control unit failed to ensure compliance with Current Good Manufacturing Practice (CGMP) regulations, and the facility did not maintain defined areas to prevent contamination or mix-ups in aseptic processing areas .
The inspection, conducted from January 8 to 16, 2024, at Hengrui’s manufacturing facility in Lianyungang, Jiangsu, revealed potential violations of the US Food Drug and Cosmetic (FD&C) Act as detailed in the Form 483. The FDA’s warning letter is a critical step in the regulatory process, requiring the company’s senior management to respond with a corrective action plan for immediate implementation.
In response to the FDA’s findings, Hengrui has expressed its commitment to addressing the issues raised, stating that it will actively engage experts and third-party consulting agencies to implement the FDA’s suggestions and maintain close communication until the issues are resolved. The company has also assured that product exports from the affected facility have not been impacted and that the warning letter will not significantly affect its 2024 performance .
This development underscores the challenges faced by global pharmaceutical companies in meeting stringent regulatory standards. It also serves as a reminder of the importance of robust quality control systems in ensuring the safety and efficacy of pharmaceutical products. As Hengrui works to resolve these issues, it will be critical for the company to demonstrate its commitment to compliance and to maintaining the trust of its stakeholders, including regulatory bodies, patients, and investors.- Flcube.com
