# China NMPA Inspection - Lepu Medical Technology (Beijing) Co., Ltd. - July 24, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/lepu-medical-technology-beijing-co-ltd/c4fc6ff0-6fa8-4b70-ac25-1aecca41db05/
Source feed: China

> China NMPA unannounced inspection for Lepu Medical Technology (Beijing) Co., Ltd. published July 24, 2017. Xinnopu Medical Technology (Beijing) Co., Ltd. underwent an unannounced compliance inspection from July 3-5, 2017. The inspection, conducted under the

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Xinnop Medical Technology (Beijing) Co., Ltd.
- Company Name: Lepu Medical Technology (Beijing) Co., Ltd.
- Publication Date: 2017-07-24
- Product Type: Device
- Summary: Xinnopu Medical Technology (Beijing) Co., Ltd. underwent an unannounced compliance inspection from July 3-5, 2017. The inspection, conducted under the regulatory framework of the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*, identified 11 general deficiencies. Main violations included the storage of significant quantities of hazardous chemicals (acetone, isopropanol, ethanol) within a Class 10,000 cleanroom, indicating a serious contamination risk. The company also lacked crucial cleaning records for equipment and used measuring tools with insufficient accuracy. Significant issues were found in quality control and documentation, such as the absence of management regulations for bacterial strains, improper handling of cultures by personnel, and missing or inconsistent controlled documents. Furthermore, altered records and unvalidated changes to process documentation were identified. Production records were found to be overly simplistic and incomplete, failing to accurately reflect production processes. Supplier management was inconsistent, and primary packaging materials were sourced from an environment that did not meet the required cleanliness levels. Finally, the company engaged in reworking finished products with non-conforming outer packaging. The Beijing Municipal Food and Drug Administration was instructed to mandate rectification, conduct follow-up inspections, and initiate product recalls if safety hazards are identified, subsequently reporting findings to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/lepu-medical-technology-beijing-co-ltd/e2b0350f-fc33-49c5-8fe6-6f7bffb037eb/