China NMPA Inspection - Hunan Dongting Pharmaceutical Co., Ltd. - October 30, 2014

An unannounced inspection by the State Food and Drug Administration (now NMPA), conducted from May 16th to 17th, 2014, revealed significant regulatory violations at Hunan Dongjian Pharmaceutical Co., Ltd. The inspection identified that the company's raw material inventory of donkey hides contained impurities, suggesting their improper use in the production of donkey-hide gelatin. Furthermore, random sampling of their tortoise shell gelatin and deer antler gelatin products confirmed the presence of undeclared bovine and donkey-derived ingredients, indicating a failure to meet established product composition regulations. These findings highlight serious issues with raw material control and product integrity within the company. The inspection, carried out in conjunction with local food and drug administrations, operates under the national pharmaceutical regulatory framework. Currently, the local food and drug administration is undertaking further investigation and enforcement actions to address the identified illegal and irregular activities by Hunan Dongjian Pharmaceutical Co., Ltd.