China NMPA Drug Inspection - Anhui Tonghuatang Traditional Chinese Medicine Pieces Technology Co., Ltd. - Stir-fried Gardenia

In July 2021, the Shaanxi Provincial Drug Administration published Bulletin No. 45, detailing results from its second round of drug sampling inspections. The report identified 10 batches of pharmaceutical products that failed to meet quality standards. Manufacturers cited in the report include Anguo Juyitang Pharmaceutical Co., Ltd., Gansu Guocao Pharmaceutical Co., Ltd., Qinghai Lukang Dadi Pharmaceutical Co., Ltd., and Hebei Jixintang Pharmaceutical Co., Ltd., among others. The inspections targeted products such as traditional Chinese medicine slices and specific capsules found at local pharmacies and health centers.

The main violations involved failures in physical properties, identification, content determination (potency), and extractive levels. These quality issues indicate that the drugs did not meet the specific chemical or physical profiles required for clinical use. The regulatory framework used for these assessments included the Chinese Pharmacopoeia (2015 Edition), National Drug Standards, and Shaanxi Provincial Standards for Traditional Chinese Medicine.

In response to these findings, the Shaanxi Provincial Drug Administration has directed local regulatory departments to implement control measures on the non-compliant batches. Authorities are currently conducting formal investigations and legal proceedings against the involved companies to ensure public safety and strict adherence to drug quality regulations.