China NMPA Drug Inspection - Shizhentang Badong Pharmaceutical Co., Ltd. - earth dragon

The Hubei Provincial Food and Drug Administration released a bulletin detailing drug quality sampling inspections conducted during the third quarter of 2016. These inspections covered drug production, operation, and use units across Hubei Province, revealing that 146 batches of drugs did not meet established quality standards.

Key violations encompassed a range of issues across Traditional Chinese Medicine (TCM) materials, medical institution preparations, other pharmaceutical preparations, and packaging materials. For TCM, common deficiencies included non-compliance with properties, identification, moisture content, total ash, sulfur dioxide residue, and content determination. A significant concern was instances where products were not manufactured by the labeled company or had untraceable supply chains. Medical institution and other finished preparations exhibited non-conformities such as dosage variation, microbial limits, content determination, moisture, weight variation, visible foreign matter, related substances, dissolution, and appearance. Packaging materials failed due to excessive solvent residue.

These quality failures indicated non-adherence to the Chinese Pharmacopoeia (2010 and 2015 editions), Ministry of Health Drug Standards, National Food and Drug Administration standards, and Hubei Provincial medical institution preparation standards. The regulatory body mandated that local food and drug departments investigate and address these non-compliances. Required actions include intensified follow-up sampling and testing, comprehensive tracing of problematic product sources, and prompt referral of any suspected criminal activities to public security authorities for prosecution.