China NMPA Inspection - Changsha Hairun Biotechnology Co., Ltd. - April 18, 2024

The National Medical Products Administration (NMPA) conducted unannounced inspections, revealing significant deficiencies at Changsha Hairun Biotechnology Co., Ltd., Hunan Kanglilai Medical Device Co., Ltd., and Hunan Fengsheng Medical Device Co., Ltd., as announced on April 18, 2024. Changsha Hairun Biotechnology faced issues including a lack of quality management system coverage for storage, management unawareness of regulatory requirements, non-compliant purified water systems in cleanrooms, and inadequate procurement practices, such as approving raw materials with discrepant test results and poor traceability. Its adverse event monitoring and management review processes were also ineffective. Hunan Kanglilai Medical Device exhibited problems with personnel qualifications and training effectiveness, non-compliant purified water equipment with excessive blind ends, production management failures like exceeding material ratios and incomplete sterilization records, and inconsistent quality control practices. Additionally, its adverse event reporting and analysis were insufficient. Hunan Fengsheng Medical Device, a registrant utilizing contract manufacturing, failed to ensure its quality management team operated at the registered address and used a part-time management representative from a parent company. Critical production processes were performed by its parent company without a formal quality agreement, and the registrant did not effectively oversee the contract manufacturer's quality documentation and procedures. Product release authorization was also inconsistent with internal regulations. These companies were found to be in serious non-compliance with the "Regulations on the Supervision and Administration of Medical Devices" and supporting Good Manufacturing Practice (GMP) requirements. The Hunan Provincial Drug Administration is mandated to suspend production, investigate and penalize violations, order product safety risk assessments, and recall hazardous products. Production can only resume after all deficiencies are rectified and a re-inspection is passed.