China NMPA Inspection - Henan Jinhongtang Pharmaceutical Co., Ltd. - November 21, 2017

An unannounced inspection of Henan Jinhongtang Pharmaceutical Co., Ltd. was conducted by the State Food and Drug Administration and the Changyuan County Food and Drug Administration on August 22-23, 2017, following a complaint and report. The inspection revealed that the company systematically manipulated computer times to re-conduct experiments and falsify data. Key violations included altering computer dates to backdate and supplement 18-month stability studies for Xiaor Resuqing Syrup and Huaijiao Pills, re-analyzing intermediate products of Huanglian Shangqing Tablets, and falsely re-analyzing the third-month stability study of Ningshen Buxin Tablets on dates when the liquid chromatography system was not operational. These actions represent serious breaches of the "Good Manufacturing Practice for Pharmaceuticals" (2010 Revision). Consequently, the Henan Provincial Food and Drug Administration has revoked the company's relevant GMP certificates. The State Food and Drug Administration has further mandated the provincial authorities to thoroughly investigate and prosecute all identified illegal and irregular activities.