China NMPA Drug Inspection - Bozhou Xinghe Pharmaceutical Co., Ltd. - Fritillaria cirrhosa

The Jiangsu Province 2017 Issue 1 Drug Quality Bulletin, released on May 4, 2017, detailed findings from inspections of various pharmaceutical products in China. The bulletin identified numerous instances of non-compliance across a wide range of manufacturers and drug categories, including chemical drugs, antibiotics, biochemical drugs, traditional Chinese medicines, and processed herbal materials. Key violations frequently observed included failures in product quality and manufacturing standards. For finished pharmaceutical products, common issues encompassed 'related substances' (impurities), 'microbial limits' (bacterial, mold, and yeast counts), 'weight variation' (inconsistent dosage), 'moisture content' deviations, and 'content determination' discrepancies, suggesting incorrect active ingredient levels. Examples include Vitamin K1 Injection and Fluconazole Capsules. For traditional Chinese medicinal materials and prepared slices, non-compliances typically related to 'moisture,' 'extractives,' 'content determination,' and deviations in 'properties' or 'appearance.' These issues were assessed against established regulatory frameworks, primarily the Chinese Pharmacopoeia (various editions), Ministry of Health Drug Standards, and specific National Food and Drug Administration Standards. While the bulletin clearly identifies the deficiencies and applicable standards, it does not explicitly detail the required corrective actions for each non-compliant entity, though such findings typically necessitate immediate remedial measures from the involved companies to ensure product quality and public safety.