China NMPA Drug Inspection - Heilongjiang Tianyi Pharmaceutical Co., Ltd. - Kebi Gutai Capsules

The Hubei Province Drug Quality Announcement (Issue 3, 2018), published on November 5, 2018, summarizes drug quality inspections conducted during the third quarter of 2018. The Hubei Provincial Food and Drug Administration led these comprehensive sampling inspections across various drug production, distribution, and healthcare facilities. The findings revealed that 107 batches of drugs failed to comply with established quality standards. Violations encompassed a broad spectrum of issues across finished pharmaceutical preparations, traditional Chinese medicinal materials, and hospital-compounded medications. Common deficiencies included deviations in physicochemical properties such as pH levels, moisture content, dissolution rates, and related impurities, alongside problems with product identification and content uniformity. A critical concern highlighted was the detection of 23 batches of counterfeit drugs, implicating various manufacturers including Jilin Lihua Pharmaceutical, Guizhou Jingfeng Injection, Bayer HealthCare Manufacturing, and Shaanxi Junbisha Pharmaceutical, among others. These regulatory actions are governed by the "Drug Administration Law of the Republic of China" and national drug standards, including the Chinese Pharmacopoeia. Local food and drug administration departments are mandated to promptly investigate and address all non-compliant drugs and associated entities. Additionally, a thorough investigation into the supply chain of unverified or counterfeit products is required, with any suspected criminal activity to be referred to public security authorities for legal action. This proactive enforcement aims to uphold drug safety and public health.