China NMPA Inspection - Yunnan Haodi Medical Equipment Co., Ltd. - July 14, 2017

An unannounced inspection conducted by the State Food and Drug Administration (SFDA) from June 23-24, 2017, identified significant non-compliance at Yunnan Haodi Medical Device Co., Ltd. The inspection, carried out under the "Measures for Unannounced Inspections of Drugs and Medical Devices" and referencing the "Regulations on the Supervision and Administration of Medical Devices" and "Good Manufacturing Practice for Medical Devices" (including the appendix for Sterile Medical Devices), revealed serious issues in the company's production quality management system, particularly concerning its Disposable Infusion Set with Needle product. A critical serious defect involved severe discrepancies in production records for batch 20170503, where the quantity of components received did not match the quantity issued for assembly, indicating a fundamental breakdown in traceability and inventory control. Another serious defect noted incomplete process control documentation, as the sealing process record lacked critical parameters like machine speed. Additionally, 15 general defects were identified, including an inadequately staffed quality department relative to production scale and deficiencies in document control procedures. As a result, Yunnan Haodi Medical Device Co., Ltd. has been ordered to immediately suspend production for comprehensive rectification. The provincial administration must take serious legal action for any detected violations and publicly disclose the company's rectification progress and regulatory measures. Production can only resume after all deficiencies are fully addressed and a successful follow-up inspection is completed. The Yunnan Provincial Food and Drug Administration is also directed to strengthen its ongoing supervision to ensure strict adherence to quality management responsibilities and manufacturing practices for medical device safety and effectiveness.