China NMPA Inspection - Jiangxi Hongxin Medical Device Group Co., Ltd. - June 23, 2017

On June 21, 2017, the State Food and Drug Administration announced findings from a recent unannounced inspection of Jiangxi Hongxin Medical Device Group Co., Ltd. The inspection revealed severe deficiencies across the company's quality management system, indicating significant non-compliance with the "Good Manufacturing Practice for Medical Devices" and related regulatory frameworks. Violations included critical understaffing in the quality management department and concurrent roles for key personnel. Plant and facilities issues comprised damaged pressure gauges, unsealed doors, and improperly functioning material transfer windows, all posing contamination risks. Equipment deficiencies included expired calibration certificates for critical instruments and an inadequate purified water system, evidenced by rust-colored water and incomplete validation records. Document control was severely lacking, with uncontrolled paper and electronic versions of critical documents found. Further issues were identified in design and development, where product material and process changes lacked proper records and risk assessments. Production management showed incomplete and non-standard batch records, missing traceability information, and inadequate segregation of qualified and unqualified products. Quality control suffered from absent raw material inspection records and traceability failures for finished products. As a result, Jiangxi Hongxin Medical Device Group Co., Ltd. has been ordered to immediately cease production and undertake comprehensive rectification. The company must assess product safety risks, recall any hazardous products in accordance with the "Regulations on the Recall of Medical Devices," and can only resume production after successfully passing a follow-up inspection by the provincial food and drug administration. Serious legal actions will be taken for violations of the "Regulations on the Supervision and Administration of Medical Devices."