China NMPA Drug Inspection - Xian Lijun Pharmaceutical Co., Ltd - Gentamicin sulfate injection

The Henan Provincial Food and Drug Administration, operating under the NMPA framework, announced the results of comprehensive drug quality supervision and sampling inspections conducted during the second half of 2012. These inspections were part of the "2012 Henan Province Drug Quality Supervision and Sampling Inspection Work Plan," aimed at enhancing drug quality and safeguarding public health.

The essential medicines inspection sampled 2,585 batches, revealing four substandard batches from manufacturers such as Yabao Pharmaceutical Group Co., Ltd., Changchun Dirui Pharmaceutical Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., and Jinan Yongning Pharmaceutical Co., Ltd. Key violations included deficiencies in content uniformity, dissolution, chemical content, and product properties, assessed against standards like the State Food and Drug Administration National Drug Standard and the Chinese Pharmacopoeia.

Separately, routine drug supervision covered 8,834 batches, identifying fourteen non-compliant batches. These involved several companies, including Jilin Tonghua Boxiang Pharmaceutical Co., Ltd., Shanxi Fenhe Pharmaceutical Co., Ltd., Jinan Limin Pharmaceutical Co., Ltd., Jiangzhong Pharmaceutical Co., Ltd., and Anhui Lianyi Pharmaceutical Co., Ltd. Common issues ranged from identification, weight discrepancies, pH imbalances, and visible foreign matter to solubility problems. Some samples were also alleged to be counterfeit. All findings were evaluated against the Chinese Pharmacopoeia and Ministry of Health Drug Standards.

As a corrective measure, municipal food and drug administrations were instructed to legally investigate all identified substandard drugs and associated entities, with a deadline of August 30, 2013, to submit their investigation results to the provincial administration.