China NMPA Drug Inspection - Guangdong Yifang Pharmaceutical Co., Ltd - Cold Relief Granules

The Guangxi Zhuang Autonomous Region Food and Drug Administration (GxFDA), operating under the National Medical Products Administration (NMPA) framework, issued a drug quality announcement on May 31, 2018. This announcement detailed findings from drug quality sampling inspections conducted as part of a provincial drug sampling plan, aiming to enhance drug quality supervision and ensure public medication safety.The inspections identified four batches of drugs from various manufacturers that failed to meet established quality standards. Specifically, Henan Baiquan Pharmaceutical Co., Ltd.'s Shujin Huoxue Tablets and Guangxi Chunzhengtang Pharmaceutical Co., Ltd.'s Bismuth Subnitrate Tablets exhibited "Weight Difference" issues. Guangdong Guoyitang Pharmaceutical Co., Ltd.'s Ganmaoling Granules were found non-compliant in "Content Determination" for an active ingredient, and Luoyang Shunshi Pharmaceutical Co., Ltd.'s Sanhuang Tablets failed "Appearance" specifications. These violations were assessed against national drug standards, including the Chinese Pharmacopoeia.In response to these deficiencies, the GxFDA promptly implemented control measures. These actions included sealing, seizing, and suspending the sale of the non-compliant drug batches. Additionally, investigations were initiated to address the source units responsible for these quality failures, ensuring accountability and adherence to regulatory requirements.