China NMPA Drug Inspection - Hebei Anguo Zhenyu Pharmaceutical Co., Ltd. - Ground maple bark

On September 10, 2018, the Inner Mongolia Autonomous Region Food and Drug Administration (IMFDA) issued an announcement, based on tests by the Hohhot Food and Drug Inspection Institute, detailing quality deficiencies in 13 batches of Dihuangpi, a traditional medicinal herb. These non-compliant products were manufactured by 13 enterprises, including Anguo Qiao Traditional Chinese Medicine Pieces Co., Ltd., Hebei Anguo Zhenyu Pharmaceutical Co., Ltd., and several others.

The main violations identified were related to the drugs' appearance and identification, indicating a failure to meet established quality standards. Such issues often stem from inadequate raw materials, processing techniques, or storage conditions, directly impacting product quality and efficacy. In response, regulatory authorities initiated immediate control measures, including the sealing and seizure of the affected drug batches. The implicated companies were mandated to suspend sales and use, recall the substandard products, and undertake necessary corrective actions.

Further, the IMFDA directed local food and drug administration departments to launch investigations into the involved enterprises. These investigations, conducted under Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China, are required to be completed, and their findings publicized, within three months of the inspection reports' receipt, ensuring regulatory compliance and public health protection.