# China NMPA Inspection - Shandong Yixing Medical Equipment Co., Ltd. - July 16, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shandong-yixing-medical-equipment-co-ltd/920caf20-3c38-4877-9128-24057fb7b9be/
Source feed: China

> China NMPA unannounced inspection for Shandong Yixing Medical Equipment Co., Ltd. published July 16, 2018. An unannounced inspection of Shandong Yixing Medical Device Co., Ltd. was conducted from June 28-30, 2018, based on the Good Manufacturing Practice fo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shandong Yixing Medical Equipment Co., Ltd.
- Company Name: Shandong Yixing Medical Equipment Co., Ltd.
- Publication Date: 2018-07-16
- Product Type: Device
- Summary: An unannounced inspection of Shandong Yixing Medical Device Co., Ltd. was conducted from June 28-30, 2018, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices. The inspection revealed 14 minor deficiencies, highlighting significant gaps in the company's quality management system and adherence to regulatory requirements.Key issues identified included inadequate management reviews that omitted adverse event and non-conforming product analysis, and insufficient training for personnel accessing clean areas. Environmental control failures were evident, such as insects entering a Class 100,000 clean area due to a poorly sealed door, and a failure to maintain air conditioning systems and replace high-efficiency filters as required since 2016.Regarding production and material control, the company lacked clear acceptance criteria for purchased raw materials, specifically for PVC granules and infusion needles, and failed to test for fluorescent substances in critical components. Sterilization processes showed deficiencies, including an ethylene oxide sterilization run performed without assessing overload conditions and a reconfirmation report lacking crucial data analysis. Packaging validation was also found to be inadequate, with discrepancies between validated and actual sealing parameters. Furthermore, the company demonstrated poor control over non-conforming products, failing to conduct root cause analysis or implement corrective actions for identified contamination. Incomplete handling of customer quality feedback was also noted.The Shandong Provincial Food and Drug Administration has mandated that the company rectify these issues promptly, assess product safety risks, and implement necessary corrective measures. Follow-up inspections may be conducted to ensure compliance.

Company: https://www.globalkeysolutions.net/companies/shandong-yixing-medical-equipment-co-ltd/d3ea3daa-2a11-4a60-8def-8e3e5424d696/