China NMPA Inspection - Guangxi Shuangjian Technology Co., Ltd. - July 14, 2017

A recent unannounced inspection by the State Food and Drug Administration of Guangxi Shuangjian Technology Co., Ltd., likely conducted in mid-2017, revealed significant non-compliance with the *Good Manufacturing Practice for Medical Devices* and its related appendices. The inspection uncovered critical deficiencies across multiple areas of the company's quality management system.

Key violations included inadequate professional knowledge and training for quality inspectors, alongside poor personnel hygiene practices like wearing jewelry and using expired disinfectants in clean areas. Facility issues were prominent, featuring an unreasonable plant layout, air conditioning drips, insect infestation, non-functional differential pressure gauges, and improper handling and labeling of cleanroom garments and equipment. Equipment deficiencies included the absence of UV lamps in critical pass-through windows.

Furthermore, the company exhibited severe document management failures, with inconsistent production records and raw material inventory, and a lack of traceability. Design and development processes were non-compliant, lacking records for design changes or risk analysis for a key product. Lastly, procurement controls were not implemented according to the company's own revised procedures. Guangxi Shuangjian Technology Co., Ltd. is required to undertake immediate and comprehensive corrective actions to address these systemic failures and bring its operations into full compliance with the regulatory framework.