# China NMPA Inspection - Chongqing Jingyu Laser Technology Co., Ltd. - May 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/chongqing-jingyu-laser-technology-co-ltd/075c7f4e-53ba-4e1e-a895-b2c7316ed9dc/
Source feed: China

> China NMPA unannounced inspection for Chongqing Jingyu Laser Technology Co., Ltd. published May 09, 2018. Chongqing Jingyu Laser Technology Co., Ltd. underwent an unannounced compliance inspection by the FDA NMPA from April 19-20, 2018. The inspection, con

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Chongqing Jingyu Laser Technology Co., Ltd.
- Company Name: Chongqing Jingyu Laser Technology Co., Ltd.
- Publication Date: 2018-05-09
- Product Type: Device
- Summary: Chongqing Jingyu Laser Technology Co., Ltd. underwent an unannounced compliance inspection by the FDA NMPA from April 19-20, 2018. The inspection, conducted under the Good Manufacturing Practice for Medical Devices, uncovered nine general deficiencies impacting the company's quality and safety protocols. Key violations included management's unfamiliarity with regulatory requirements for registration certificate renewals and changes. The company failed to properly label and track hardware components on the production floor and maintained incomplete equipment operation records, lacking detailed start-up and shutdown times. Furthermore, supplier re-evaluation records for critical components like KTP crystals were found unreadable due to language barriers and poor document retention. Purchased materials were not adequately checked against inspection reports by batch number, and supplier self-inspection reports lacked necessary batch descriptions. A significant issue was the use of an expired calibration certificate for the laser power/energy meter.

Additionally, inspection reports for raw materials and semi-finished products were not properly differentiated and lacked crucial details regarding time, environment, and specific experimental procedures. The company also failed to establish a "Product Scrap Management System" and its "Data Analysis and Control Procedure" was inconsistent, omitting adverse event data analysis and not utilizing stipulated statistical methods like Pareto charts. As a result, the Chongqing Municipal Food and Drug Administration was directed to mandate the company's rectification within a specified timeframe, potentially conducting follow-up inspections. Chongqing Jingyu Laser Technology Co., Ltd. must assess product safety risks and recall any products posing hazards, with the regulatory authority reporting the rectification status to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/chongqing-jingyu-laser-technology-co-ltd/d542c99a-8103-4f64-b0d3-acbcdea93b31/