China NMPA Drug Inspection - Hubei Qingda Traditional Chinese Medicine Pieces Co., Ltd. - Cassia seeds (raw cassia seeds)

The Shanghai Municipal Food and Drug Administration (SFDA) issued its 2018 Issue 7 Drug Supervision and Sampling Quality Announcement on July 31, 2018. This announcement detailed the results of quality supervision and sampling inspections conducted across drug production, operation, and use units in Shanghai. The initiative aimed to enhance quality management, regulate market order, and ensure the safety of marketed drugs and pharmaceutical packaging materials.

Key violations identified included issues with drug properties, identification, impurity levels, ash content, appearance, processing methods, and active ingredient content determination. Companies implicated in non-compliance across both circulation/use and production stages included Anhui Jinfurong Traditional Chinese Medicine Slices Co., Ltd., Shanghai Hongqiao Traditional Chinese Medicine Pieces Co., Ltd., Hunan Xiangzhong Pharmaceutical Co., Ltd., Hubei Jingui Traditional Chinese Medicine Pieces Co., Ltd., and Shanghai Huaying Pharmaceutical Co., Ltd., among others. These inspections were carried out under the regulatory guidelines of the 2015 Edition Chinese Pharmacopoeia and the 2008 Edition Shanghai Processing Regulations.

As required actions, the SFDA mandated that units immediately suspend sales and use of unqualified products, initiate product recalls, and implement comprehensive rectification measures. Regulatory departments were instructed to investigate and handle these cases according to legal provisions. Additionally, local market supervision bureaus are to strengthen daily oversight, ensure enterprises identify root causes, and execute corrective actions to eliminate potential risks, with the SFDA committing to ongoing follow-up inspections.