China NMPA Drug Inspection - Chongqing Knight Hospital - Calamine lotion

The Chongqing Municipal Drug Administration's 2018 Issue No. 2 Drug Quality Announcement detailed findings of substandard pharmaceutical products from two entities: Chongqing Knight Hospital (also referred to as Chongqing Qishi Hospital) and Chongqing Kangjia Pharmaceutical Co., Ltd. Published on December 29, 2018, the report identified three specific batches of drugs that failed to meet national quality standards following inspections by local food and drug testing institutes. The violations involved Calamine Lotion and Yixin Bunao Mixture from Chongqing Knight Hospital, which failed borax content and quantity determination tests, respectively. Additionally, a batch of Lotus Seed Heart produced by Chongqing Kangjia Pharmaceutical was found non-compliant regarding its content determination. In response to these findings, the Jiangbei and Hechuan District regulatory branches executed immediate enforcement actions under China's drug administration laws. These measures included sealing and seizing existing stock, suspending sales, and initiating product recalls to protect public health. The regulatory framework requires the manufacturers to conduct thorough internal investigations to identify the root causes of these quality failures. Furthermore, the companies must formulate and implement formal rectification measures to eliminate potential safety risks and ensure future compliance with pharmaceutical standards.