# China NMPA Inspection - Sinocare Medical Science and Technology Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/sinocare-medical-science-and-technology-co-ltd/b8b033a0-9888-4eaf-871e-0b1ac927755a/
Source feed: China

> China NMPA unannounced inspection for Sinocare Medical Science and Technology Co., Ltd. published August 15, 2018. An unannounced inspection of Sinocare Medical Science & Technology Co., Ltd., focusing on its Biodegradable Drug-Coated Coronary Stent System, was con

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Sinocare Medical Science and Technology Co., Ltd.
- Company Name: Sinocare Medical Science and Technology Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: An unannounced inspection of Sinocare Medical Science & Technology Co., Ltd., focusing on its Biodegradable Drug-Coated Coronary Stent System, was conducted from July 10-11, 2018. The inspection, guided by the Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices, revealed several significant non-conformities within the company's quality management system.Key issues included the lack of usage records for critical production equipment, such as drug spraying machines, and the failure to calibrate or manage pressure gauges used for nitrogen and oxygen supply. The company also deviated from its established Standard Operating Procedure for spraying solution preparation, using solutions in production before completing required testing. Furthermore, there were deficiencies in record-keeping, specifically incomplete usage records for Staphylococcus aureus and missing original inspection data for certain semi-finished product batches. Daily monitoring records for the water purification system's conductivity and pH were also absent, and the company could not provide sufficient justification for its sampling rules in standard operating procedures.Consequently, the Tianjin Municipal Market and Quality Supervision and Management Commission was tasked with requiring Sinocare to rectify these deficiencies within a specified period. The company must assess product safety risks, potentially initiating recalls for any hazardous products. Follow-up inspections are anticipated, and the rectification status must be reported to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/sinocare-medical-science-and-technology-co-ltd/76236c28-47c1-4fcf-8b46-de22c2afc2d8/