China NMPA Drug Inspection - Tonghua Sway Pharmaceutical Co., Ltd. - Anti-inflammatory and cough suppressant tablets

The Hubei Province Drug Quality Bulletin, issued by the Hubei Provincial Food and Drug Administration, detailed the outcomes of drug quality supervision and sampling inspections conducted during the second quarter of 2014. These inspections involved 1360 batches of drugs and pharmaceutical packaging materials from manufacturers, distributors, and medical facilities throughout the province. From this extensive sampling, 75 batches were found to be non-compliant with established standards.

Despite an overall assessment of good product quality, several critical issues emerged. Prominent deficiencies included inadequate procurement of medicinal materials, insufficient production process controls, especially among Traditional Chinese Medicine (TCM) decoction piece manufacturers, and problems maintaining proper conditions for drug transportation and storage. Specific violations, referencing the Chinese Pharmacopoeia 2010 Edition, frequently involved incorrect content determination (e.g., White Peony Root), excessive sulfur dioxide residues in various TCMs, detection of banned adulterants like Auramine O (in Phellodendron amurense and Coptis chinensis), and misidentification of herbal medicines. Additionally, some packaging materials exhibited non-compliance, and several products were marked with misleading production information, indicating supply chain integrity concerns.

The Provincial Bureau mandated that regulatory bodies rigorously investigate and legally address all non-compliant drugs. Enterprises are required to identify root causes, implement corrective actions, and eliminate potential risks to ensure drug quality and public safety.