China NMPA Drug Inspection - Henan Kanghua Pharmaceutical Co., Ltd. - Poria

The Henan Provincial Food and Drug Administration (NMPA) issued a Drug Quality Bulletin on May 18, 2015, detailing drug sampling inspections conducted throughout Henan Province during the second half of 2014. These inspections, part of the '2014 Henan Province Drug Sampling Inspection Work Plan,' covered 15,821 batches of various drug categories. The regulatory framework for assessment primarily included the Chinese Pharmacopoeia 2010 Edition (Parts I and II), national drug standards, and specific Henan Provincial Food and Drug Administration preparation standards.

The inspections identified 62 batches of drugs from numerous pharmaceutical manufacturers and medical institutions that failed to meet quality standards. Key violations included widespread quality control deficiencies such as excessive moisture content, insufficient active ingredient levels, and non-compliance in critical parameters like dissolution rates, microbial limits, identification (e.g., thin-layer chromatography), total ash, sulfur dioxide residue, appearance, and fill weight. The main issues often pointed to problems in raw material quality, processing, or manufacturing practices. The bulletin publicly announced these substandard drugs to strengthen drug quality supervision and ensure public medication safety, implying that the implicated companies and institutions must undertake corrective actions and recalls.