China NMPA Drug Inspection - Jiangsu NHWA Pharmaceutical Co., Ltd. - Fukangning Capsules

On April 5, 2017, the Fujian Province Drug Quality Announcement (Issue No. 64) was released, detailing findings from supervision and sampling inspections by provincial and municipal food and drug regulatory bodies across Fujian. These inspections, conducted to safeguard public medication safety, identified 13 batches of drugs that did not comply with established quality standards. Key issues included dissolution failures for Isosorbide Nitrate Tablets manufactured by Handan Jinan Pharmaceutical Co., Ltd., and content non-compliance for Fukangning Capsules from Jiangsu Yihai Pharmaceutical Co., Ltd., Baoji Pills by Guangdong Province Luofu Mountain Baihe Pharmaceutical Factory, Diclofenac Sodium Enteric-coated Tablets from Jilin Jiuyang Pharmaceutical Co., Ltd., and Oral Rehydration Salt Powder (I) from Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd. Traditional Chinese Medicine product manufacturers, such as Jiangxi Zhangshu Qingren, Jiangxi Qirentang, Jiangxi Zhihetang, and Longxi County Baochuan Traditional Chinese Medicine Pieces Co., Ltd., faced citations primarily for issues concerning product appearance for items like Rhubarb, Fangfeng, Ophiopogon japonicus, Drynaria fortunei, and Bupleurum. Additionally, Angelica dahurica from Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd. was found to have excessive sulfur dioxide residue. These violations were assessed under the "Drug Administration Law of the People's Republic of China," its implementing regulations, and relevant editions of the Chinese Pharmacopoeia. Regulatory departments are actively investigating and processing these non-compliance cases in accordance with the law to ensure product integrity and public health.