China NMPA Drug Inspection - Xi"an Jingxi Shuanghe Pharmaceutical Co., Ltd. - Sodium chloride injection

The Ningxia Food and Drug Administration released an announcement on July 30, 2018, detailing the outcomes of its regional drug quality sampling inspections. These assessments, carried out by various drug regulatory departments and testing institutions, encompassed 90 batches from 49 different drug varieties. Specifically, the inspection covered 15 batches of 3 chemical drug varieties and 75 batches of 46 traditional Chinese medicine decoction pieces. The sampled products involved numerous manufacturers, including Ningxia Mingde Traditional Chinese Medicine Pieces Co., Ltd., Yichang Renfu Pharmaceutical Co., Ltd., Sichuan Kelun Pharmaceutical Co., Ltd., and Ningxia Northwest Medicinal Herbs Technology Co., Ltd., among others. The regulatory framework applied for these inspections was primarily the Chinese Pharmacopoeia 2015 Edition (Parts I and II), with some traditional Chinese medicine items also referencing the 1997 Ningxia Traditional Chinese Medicine Processing Standards and the 1990 Chinese Pharmacopoeia, Part I. Notably, the comprehensive review revealed no violations or quality issues; all inspected batches were found to be fully compliant with the applicable standards. As a result, no specific corrective actions were mandated for any of the implicated companies or products.