两家检测机构收FDA警告信 江苏科标暂停相关非临床测试服务

Core Points - Two Chinese companies, Jiangsu Kebiao Medical Technology Group and Zhongjian Huatuo Wei International Inspection, received warning letters from the FDA regarding compliance issues in their non-clinical testing services [1][2][4] - Jiangsu Kebiao has suspended all FDA-related non-clinical testing services for a minimum of three years, until December 31, 2027, due to the inability to bear the costs of a comprehensive compliance system [3][4] Company Summaries - Jiangsu Kebiao, established in 2015, is a third-party testing organization focused on medical devices, materials, cosmetics, and packaging, with a registered capital of 17.62 million yuan [3] - The company specializes in safety and efficacy evaluations for implantable and interventional products and has completed a Series A financing round in 2024, amounting to several million yuan [3] - Zhongjian Huatuo Wei, founded in 2017, primarily operates in the professional technical services sector and was also found to have significant compliance issues during an FDA inspection [4] Compliance Issues - The FDA inspections revealed serious non-compliance issues at both companies, including failures in data management, execution processes, and lack of proper documentation and standard operating procedures [2][4] - Jiangsu Kebiao's inspection highlighted multiple failures by the research leader, including not ensuring that research protocols were approved and followed, and not maintaining accurate records of laboratory data [2] - Zhongjian Huatuo Wei's inspection found issues such as failure to accurately record and verify experimental data and not providing a mechanism for orderly storage and quick retrieval of original data and reports [4][5] Regulatory Actions - The FDA requires both companies to respond within 15 business days with corrective and preventive action plans to address the identified violations [5] - Failure to take appropriate corrective measures may result in further regulatory actions, including the potential revocation of their operational qualifications [5]