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]

Core Points - Two Chinese companies, Jiangsu Kebiao Medical Technology Group Co., Ltd. and Zhongjian Huatuo Wei International Inspection (Suzhou) Co., Ltd., received warning letters from the FDA regarding compliance issues in their research practices [1][3] - Jiangsu Kebiao has decided to suspend all FDA-related non-clinical testing services for a minimum of three years, until December 31, 2027 [2][4] Company Overview - Jiangsu Kebiao, established in 2015 and located in Changzhou, Jiangsu, focuses on third-party testing services for medical devices, materials, cosmetics, and packaging [4] - The company has a registered capital of 17.62 million yuan and completed a Series A financing round in 2024, amounting to several million yuan [4] - The company cited intense domestic market competition as a reason for its inability to maintain a comprehensive compliance system, posing long-term challenges and risks [4] Compliance Issues - The FDA's warning letters stem from inspections conducted by the Office of Biological Research Monitoring (OBMI), which identified serious non-compliance in non-clinical Good Laboratory Practice (GLP) research [3][5] - Specific violations at Jiangsu Kebiao included failures in data management, lack of proper approval for research protocols, and inadequate quality assurance measures [3][4] - Zhongjian Huatuo Wei was also found to have significant compliance issues, including failure to accurately record and verify experimental data and maintain proper documentation [5][6] Regulatory Requirements - The FDA requires Zhongjian Huatuo Wei to respond within 15 working days with corrective and preventive action plans to address the identified violations [6] - Failure to take appropriate corrective measures may result in further regulatory actions, including the potential revocation of the company's qualifications [6]