China NMPA Drug Inspection - Dingfukang Pharmaceutical Co., Ltd. - Ribavirin Injection

The Fujian Provincial Drug Administration published its third drug quality inspection report for 2021 on September 24, 2021. This document identifies three specific batches of pharmaceutical products that failed to meet safety and quality standards under the Drug Administration Law of the People's Republic of China and the Administrative Measures for Drug Quality Sampling Inspection. The inspections revealed violations across three manufacturers: Dingfukang Pharmaceutical Co., Ltd., Jilin Overseas Chinese Pharmaceutical Group Co., Ltd., and Anhui Huifeng Guoyao Co., Ltd. Specifically, Ribavirin Injection from Dingfukang failed content standards, while Huoxiang Zhengqi Pills from Jilin Overseas Chinese Pharmaceutical showed excessive moisture, and Xanthium Fruit from Anhui Huifeng Guoyao contained improper levels of toxic carboxy-atractylodes glycosides. These failures indicate issues with manufacturing potency, storage conditions, and herbal processing. The regulatory framework for these findings is based on the 2015 Edition of the Chinese Pharmacopoeia and Ministry-issued Standards. In response, the Fujian Provincial Drug Administration has initiated formal investigations into the manufacturers and sampled units. Required actions include the legal seizure of non-compliant batches and enforcement of corrective measures against the responsible companies to safeguard public health.