China NMPA Drug Inspection - Emeishan Tonghui Pharmaceutical Co., Ltd. - Famotidine for injection

The State Food and Drug Administration (SFDA) of China, now known as the National Medical Products Administration (NMPA), issued its National Drug Quality Bulletin (2012, No. 3) on September 24, 2012. This bulletin reported findings from a nationwide drug sampling inspection conducted prior to this date, aiming to enhance drug quality supervision and ensure public safety.The inspections covered 30 drug varieties, including 25 national essential medicines like ampicillin injection and cephalexin, and 5 other pharmaceutical preparations such as Hedyotis diffusa injection and doxophylline for injection. A total of 36 product batches were found to be non-compliant with established quality standards, including the Chinese Pharmacopoeia and national drug approval standards. Specific issues included failures in "Total Solids" for Hedyotis diffusa Injection (Anhui Fengyang Keyuan Pharmaceutical Co., Ltd.) and "Clarity and color of solution" for Famotidine for Injection (Jiangxi Gannan Haixin Pharmaceutical Co., Ltd.), along with general appearance and solution clarity problems for other manufacturers like Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd.In response, provincial food and drug administration departments were mandated to investigate and address these quality deficiencies. They were required to submit their investigation outcomes to the SFDA's Inspection Bureau by October 20, 2012, demonstrating the regulatory body's commitment to enforcing medication quality and holding manufacturers accountable.