China NMPA Drug Inspection - Yunnan Suimin Biotechnology Development Co., Ltd. - Cornus officinalis

The Guizhou Provincial Drug Administration issued Announcement No. 3, 2019, on December 2, 2019, detailing the results of drug quality sampling inspections. Conducted under a provincial supervision and sampling plan, these inspections aimed to bolster drug quality oversight and ensure public medication safety across drug production, distribution, and medical institutions.

The announcement identified nine batches of drugs from various manufacturers and suppliers as non-compliant with established quality standards. Key companies implicated include Anhui Yaozhiyuan Traditional Chinese Medicine Pieces Co., Ltd., Kunming Jingtian Pharmaceutical Co., Ltd., Yunnan Suimin Biotechnology Development Co., Ltd., Hunan Songlingtang Traditional Chinese Medicine Slices Co., Ltd., Yibin Renhe Traditional Chinese Medicine Slices Co., Ltd., Hunan Honghua Traditional Chinese Medicine Processed Herb Co., Ltd., and Hubei Ji'antang Pharmaceutical Co., Ltd.

The primary violations uniformly stemmed from non-compliance with the Chinese Pharmacopoeia 2015 Edition, Part I. Specific deficiencies noted across different Traditional Chinese Medicine (TCM) items and one compound tablet encompassed failures in "Properties," "Identification," "Extractives," "Content Determination" for active components (e.g., Icariin), and "Inspection" for moisture content. These findings indicate significant quality control lapses.

In response, food and drug regulatory departments are actively investigating and legally addressing the non-compliant drugs and associated entities. Timely control measures have been implemented for the affected products, underscoring a commitment to upholding national pharmacopoeial standards and safeguarding public health.