China NMPA Drug Inspection - Yichang Renfu Pharmaceutical - Simvastatin capsules

The Ningxia Drug Administration, operating under China's National Medical Products Administration, published an announcement on January 22, 2020, detailing drug sampling inspection results from 2019. These inspections, conducted in accordance with the "Drug Administration Law of the People's Republic of China" and related regulations, covered 94 varieties across 164 batches, including chemical drugs, traditional Chinese medicine preparations, and decoction pieces. Out of the total, 12 varieties and 14 batches were found non-compliant with established quality standards, primarily the Chinese Pharmacopoeia. Key issues identified included failures in product 'properties,' 'appearance,' and 'content determination.' A recurring problem was the inability to verify the origin or legitimacy of certain non-compliant traditional Chinese medicine pieces, with several listed manufacturers denying production, having expired licenses, or being bankrupt. One specific instance noted improper storage by a dispensing unit led to insect infestation in a traditional Chinese medicine ingredient. The regulatory authority stated that all non-compliant drugs and related entities have been investigated and are being dealt with by relevant municipal and county market supervision administrations in accordance with the law, aiming to uphold drug quality and safety standards within the region.