China NMPA Drug Inspection - Zhangjiakou Yunfeng Pharmaceutical Factory - Difenidol Hydrochloride Tablets

The State Food and Drug Administration (SFDA) of China issued a National Drug Quality Bulletin on April 18, 2012, detailing findings from nationwide sampling inspections. These inspections, conducted under the National Drug Sampling Inspection Work Plan, assessed 35 essential drug varieties and 7 other pharmaceutical preparations. Out of 42 varieties sampled, seven batches of products failed to meet established quality standards.Key violations included Guilin Nanfang Pharmaceutical Co., Ltd.'s Artesunate for Injection, found to have visible foreign matter in two batches. Zhangjiakou Yunfeng Pharmaceutical Factory's Difenidol Hydrochloride Tablets failed dissolution tests, while Guangdong Liankang Pharmaceutical Co., Ltd.'s Ranitidine Hydrochloride Capsules did not meet content determination standards. Anhui Shuangke Pharmaceutical Co., Ltd.'s Pilocarpine Nitrate Eye Drops exhibited non-compliant osmolality and visible foreign matter. Jiangxi Gannan Haixin Pharmaceutical Co., Ltd.'s Lomefloxacin Hydrochloride Sodium Chloride Injection also contained visible foreign matter.The regulatory framework for these assessments included the Chinese Pharmacopoeia (2005 and 2010 Editions) and National Drug Standards for New Drug Approval. As a required action, provincial food and drug administrations were mandated to investigate the non-compliant drugs and associated entities, submitting their findings to the SFDA's Inspection Bureau by June 20, 2012, to safeguard public drug safety.