China NMPA Inspection - Hainan Langteng Medical Equipment Co., Ltd. - December 07, 2017

Hainan Langteng Medical Equipment Co., Ltd. was subject to an unannounced compliance inspection on November 21, 2017. The inspection, based on the Good Manufacturing Practice for Medical Devices, focused on the company's production of Hemodialysis Machine Disinfectant. Inspectors found the company's production workshop and all warehouses (finished product, raw material, and packaging material) to be empty, indicating no ongoing production. This finding verified the company's previous report to the Hainan Provincial Food and Drug Administration on October 25, 2016, regarding the suspension of production for this product. Consequently, Hainan Langteng Medical Equipment Co., Ltd. is required to submit a written report to the Hainan Provincial Food and Drug Administration before any resumption of production. Operations can only recommence after the provincial administration conducts a subsequent inspection and confirms that the company meets all necessary requirements. Additionally, the Hainan Provincial Food and Drug Administration must promptly inform the Medical Device Supervision Department of the State Administration for Market Regulation about the company's production resumption status, ensuring continued adherence to regulatory standards.