China NMPA Drug Inspection - Hunan Yuxin Pharmaceutical Co., Ltd - transfer factor

The State Food and Drug Administration (SFDA) announced critical findings from follow-up sampling inspections conducted prior to October 31, 2016. These inspections revealed repeated quality failures in drug products from three pharmaceutical companies, indicating significant deficiencies in their production quality management systems.

Guizhou Tiandi Pharmaceutical Co., Ltd. had three batches (15070702A, 15070703A, 15070804A) of Dexamethasone Sodium Phosphate Injection found substandard due to issues with related substances. Guangxi Ditai Pharmaceutical Co., Ltd.'s Kang'erxin Capsules (batch 150501) failed content determination. Furthermore, Hunan Yige Pharmaceutical Co., Ltd.'s Transfer Factor (batch 150706) was found to be non-sterile. These findings represent a recurrence of issues previously identified in national drug sampling inspections.

Under the "Drug Administration Law of the People's Republic of China," the SFDA has mandated stringent actions. Provincial food and drug administrations in Guizhou, Guangxi, and Hunan have initiated product control measures, including sealing, seizing, recalling, and suspending the sale and use of the affected drugs. The companies are required to immediately cease production of the relevant products, thoroughly investigate and rectify the root causes of the quality problems, and are prohibited from resuming production until full compliance is achieved. The SFDA will pursue legal investigations against these companies, enforce penalties, publicly disclose information, and designate them as priority targets for ongoing supervision.