Expert Group of CFDA Conducts On-site Inspection and Guidance at Haorun Medical Factory

Recently, the expert team from the National Medical Products Administration (NMPA) visited Haorun Medical’s factory for on-site inspection and technical guidance. Company management, quality, production and relevant department heads accompanied the inspection.

At the opening meeting, the team clarified inspection scope and requirements. Haorun Medical presented its company profile, quality management system operation and supply chain.

The experts toured clean workshops, raw and finished goods warehouses, physical-chemical and microbiology labs. Following the Medical Device GMP, they audited facility conditions, equipment validation, incoming material testing, in-process control, batch records, traceability and adverse event monitoring. They reviewed documents and records, communicated with on-site staff, offered professional guidance and put forward optimization suggestions.

During the closing meeting, the team recognized Haorun Medical’s achievements in quality system and production management, and raised rectification requirements with clear deadlines for identified issues.

Haorun Medical will fully implement the expert team’s feedback, carry out targeted rectification and close all non-conformities. The company will continuously uphold the main responsibility for medical device safety, improve its quality management system, and provide safe, compliant medical consumables for global clients while expanding overseas markets.