China NMPA Drug Inspection - Shandong Heze Taishan Traditional Chinese Medicine Pieces Co., Ltd. - Huangbai

The Henan Provincial Food and Drug Administration (HPFDA) issued its Drug Quality Announcement (2014, Issue 1) on December 1, 2014, to report on substandard drug products identified during sampling inspections conducted in the first half of 2014. This action was part of the province's 2014 Drug Sampling Inspection Work Plan, designed to enhance pharmaceutical quality control and public safety.

The announcement detailed multiple quality deficiencies across various manufacturers, including Guangxi Shengmin Pharmaceutical Co., Ltd., Wuhu Changjiang Glass Products Co., Ltd., Chongqing Beiyuan Glass Co., Ltd., Shandong Pharmaceutical Glass Co., Ltd., Jinan Renhe Traditional Chinese Medicine Pieces Co., Ltd., Jingmen Ruikang Pharmaceutical Co., Ltd., Jinghua Pharmaceutical Bozhou Kangpu Co., Ltd., Maoming Junbang Traditional Chinese Medicine Pieces Co., Ltd., Bozhou Yonggang Traditional Chinese Medicine Pieces Co., Ltd., Shandong Heze Taishan Chinese Medicine Pieces Co., Ltd., Guizhou Shengshi Longfang Pharmaceutical Co., Ltd., Beijing Zizhu Pharmaceutical Co., Ltd., and Anhui Lei Yunshang Traditional Chinese Medicine Co., Ltd.

Key violations included discrepancies in drug contents, issues with the appearance and properties of traditional Chinese medicine ingredients, incorrect moisture content, and failures in active pharmaceutical ingredient content determination and identification. Additionally, pharmaceutical packaging, specifically low borosilicate glass ampoules, failed to meet breaking force specifications. These non-compliances indicated deviations from established standards such as the Chinese Pharmacopoeia 2010 Edition and various National Drug Administration packaging and product regulations.

The HPFDA mandated that municipal food and drug supervision administrations investigate these non-compliant products and the implicated units, initiating appropriate enforcement actions and submitting their findings by December 26, 2014. Manufacturers' responses varied, with several stating the products were "Not produced by this company," or indicating "No objection to the test results," while one company failed to respond by the deadline.