China NMPA Drug Inspection - Shanxi Fenhe Pharmaceutical Co., Ltd. - Hydrobromide Homococcus

The Shaanxi Provincial Food and Drug Administration (SPFDA) issued its "2017 Issue 12 Announcement on the Quality of Drugs Failing to Meet Regulations in Spot Checks" on December 13, 2017. This announcement detailed findings from province-wide sampling inspections aimed at strengthening drug supervision and ensuring public medication safety. Inspections identified 25 batches of non-compliant drugs from multiple manufacturers, including Baoji Hanfang Traditional Chinese Medicine Pieces Co., Ltd., Shaanxi Kangshengtang Pharmaceutical Co., Ltd., and Jiangzhong Pharmaceutical Co., Ltd. The primary quality issues cited across these batches encompassed failures in properties, identification, general inspection parameters, content determination, and extractives. Specific examples of non-compliance included discrepancies in appearance, identification, and moisture content. The regulatory framework for these inspections involved adherence to official standards such as the Chinese Pharmacopoeia (1977 and 2015 editions), the Shaanxi Provincial Standard for Traditional Chinese Medicine Decoction Pieces (2008 Edition), and specific National Drug Administration and Ministry of Health Drug Standards. In response to these findings, local food and drug regulatory departments have implemented necessary control measures for the affected units. Further investigations and legal actions are being pursued in accordance with pertinent laws and regulations to address the identified quality deficiencies, underscoring the SPFDA's commitment to upholding drug quality standards.