China NMPA Drug Inspection - No manufacturer indicated - Agrimony

The Jiangsu Province 2018 First Issue Drug Quality Bulletin, published on March 20, 2018, details findings from comprehensive drug quality inspections. The bulletin identifies numerous violations across a wide range of pharmaceutical products, including chemical drugs, antibiotics, biochemical drugs, traditional Chinese medicines, and hospital preparations. Many manufacturers were cited for non-compliance; for instance, Shandong Sibangde Pharmaceutical Co., Ltd.'s Valsartan Hydrochlorothiazide Dispersible Tablets failed dissolution tests, while Jiangsu Pengyao Pharmaceutical Co., Ltd. was cited for visible foreign matter in Metoclopramide Hydrochloride Injection. Traditional Chinese medicinal materials and prepared pieces from companies like Anhui Fengyuan Tongling Traditional Chinese Medicine Pieces Co., Ltd. and Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. frequently failed appearance, content determination, or purity tests, with several manufacturers denying production. A hospital preparation from Nanjing Integrated Traditional Chinese and Western Medicine Hospital also showed content weight differences. The regulatory framework for these inspections included the Chinese Pharmacopoeia (2010 and 2015 Editions), National Food and Drug Administration Standards, Ministry of Health Drug Standards, and Jiangsu Province-specific processing standards. Common violations spanned critical quality attributes such as dissolution, related substances, visible foreign matter, content accuracy, appearance, microbial limits, moisture, total ash, and identification. While specific required actions for each company are not detailed in this bulletin, the widespread non-compliance necessitates immediate corrective measures by the identified manufacturers and further investigation into product origins, particularly where manufacturers deny production, to ensure adherence to established drug quality and safety standards.