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

An unannounced inspection by the State Food and Drug Administration (NMPA), conducted between June 20-21, 2017, identified significant quality management system deficiencies at Guangxi Shuangjian Technology Co., Ltd., a manufacturer of disposable infusion sets with needles. The inspection, carried out under the “Measures for Unannounced Inspections of Drugs and Medical Devices,” revealed non-compliance with the "Good Manufacturing Practice for Medical Devices" and its "Appendix: Sterile Medical Devices."

Major violations included a lack of essential professional knowledge among Quality Department inspectors concerning critical testing, inadequate control over material flow posing contamination risks between workshops, and the company's inability to perform necessary purified water quality tests. Additionally, cleanroom pass-through windows lacked required UV lamps. Significant documentation inconsistencies were also noted, such as missing production batch records for recycled materials and discrepancies in inventory and product receiving logs.

Consequently, the company was ordered to immediately cease production and rectify all identified issues. The regulatory body mandated serious handling of violations according to the "Regulations on the Supervision and Administration of Medical Devices." The local FDA was instructed to publicly disclose the company's production suspension, rectification progress, and regulatory actions. Production resumption is conditional on comprehensive rectification and a successful follow-up inspection. The administration was also urged to enhance daily supervision to ensure adherence to quality management responsibilities and product safety.