China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - Chinese herbal medicine slices

The Shandong Provincial Food and Drug Administration, operating under the National Medical Products Administration (NMPA), issued an announcement on January 24, 2018 (republished on November 18, 2019), detailing significant quality issues found in Traditional Chinese Medicine (TCM) decoction pieces. Testing conducted by nine drug testing institutions, including the Jinan and Jining Municipal Food and Drug Inspection and Testing Centers, identified 32 batches of products from 24 enterprises as substandard. Companies such as Bozhou Chengyuan TCM Decoction Pieces Co., Ltd. and Shandong Shangdu Pharmaceutical Co., Ltd. were among those cited. The primary violations pertained to quality defects identified during "appearance and inspection," affecting 25 types of TCM decoction pieces, including Bletilla striata and Pheretima aspergillum. In response, relevant municipal food and drug administrations enacted strict control measures. These actions included sealing and seizing non-compliant batches, suspending product sales, and initiating recalls of the substandard drugs. Furthermore, legal cases were filed against the responsible manufacturers and sampled units. All implicated enterprises are now required to thoroughly investigate the underlying causes of these deficiencies, formulate and implement comprehensive rectification plans, and effectively eliminate potential risks to ensure product quality and public safety.