China NMPA Drug Inspection - Anhui Dechang Pharmaceutical Slices Co., Ltd. - Bai Wei

The Gansu Provincial Drug Administration released a Drug Quality Announcement on November 26, 2019, identifying 20 batches of substandard drugs produced by 19 enterprises, with Gansu Guanlan Traditional Chinese Medicine Pieces Co., Ltd. being a prominently cited manufacturer. The inspections were primarily conducted against the Chinese Pharmacopoeia 2015 Edition, Part I, and its supplements. Key violations across various traditional Chinese medicinal ingredients included non-compliance with specifications related to Total Ash, Extractives, Properties, Content Determination, Microscopic Identification, Thin-Layer Chromatography, and the presence of impurities such as insect infestation.

Regulatory actions have been swiftly implemented by market supervision departments, including the sealing and seizing of non-compliant products. Investigations against the responsible entities have commenced, with commitments to publicize the findings within three months. Furthermore, municipal and prefectural supervision bureaus are instructed to enhance oversight, ensuring that these companies conduct thorough root cause analyses, develop, and execute rectification measures to effectively mitigate potential risks to drug quality and public safety.