# China NMPA Inspection - Chengdu Xinxing Endoscopy Technology Co., Ltd. - September 29, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/chengdu-xinxing-endoscopy-technology-co-ltd/54ee9c47-f268-4fe9-b14e-2c289c3d3fac/
Source feed: China

> China NMPA unannounced inspection for Chengdu Xinxing Endoscopy Technology Co., Ltd. published September 29, 2018. An unannounced inspection of Chengdu Xinxing Endoscopy Technology Co., Ltd. was conducted from September 4-5, 2018, based on the Good Manufacturing Pr

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Chengdu Emerging Endoscopy Technology Co., Ltd.
- Company Name: Chengdu Xinxing Endoscopy Technology Co., Ltd.
- Publication Date: 2018-09-29
- Product Type: Device
- Summary: An unannounced inspection of Chengdu Xinxing Endoscopy Technology Co., Ltd. was conducted from September 4-5, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection revealed several significant deficiencies in the company's quality management system and production processes for Electronic Laparoscopes. Key issues identified include insufficient practical problem-solving skills among technical and quality management staff, and a lack of assessment for potential interactions between various manufacturing equipment like air compressors and UV sterilizers. The facility also presented inadequate storage conditions for materials, including raw stainless steel pipes, and lacked proper verification records for critical machinery. Essential design and development procedures were found to omit risk management content. Furthermore, production records for electronic laparoscopes were incomplete, missing crucial details such as quantities, specifications, and operator information. Control over inspection equipment handling and storage was absent, and specific product records, including process inspection and certificates of conformity for product number 00095, were missing or incorrect. The company also failed to establish proper rework control documents for non-conforming products and did not conduct root cause analysis or implement preventive measures for customer complaints. The Sichuan Provincial Food and Drug Administration has mandated that Chengdu Xinxing rectify all identified issues within a specified timeframe, assess product safety risks, and initiate recalls for any hazardous products. Follow-up inspections will be conducted, and a report submitted to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/chengdu-xinxing-endoscopy-technology-co-ltd/6304e299-4f60-41ae-bacc-40a9069a34ea/