# China NMPA Inspection - Shaanxi Ruisheng Biotechnology Co., Ltd. - October 12, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/shaanxi-ruisheng-biotechnology-co-ltd/8cba7368-9294-41d3-a56f-54566785ca76/
Source feed: China

> China NMPA unannounced inspection for Shaanxi Ruisheng Biotechnology Co., Ltd. published October 12, 2017. Shaanxi Ruisheng Biotechnology Co., Ltd. was subject to an unannounced compliance inspection from September 12-13, 2017, focusing on their production 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shaanxi Ruisheng Biotechnology Co., Ltd.
- Company Name: Shaanxi Ruisheng Biotechnology Co., Ltd.
- Publication Date: 2017-10-12
- Product Type: Device
- Summary: Shaanxi Ruisheng Biotechnology Co., Ltd. was subject to an unannounced compliance inspection from September 12-13, 2017, focusing on their production of Natural Calcined Bone Repair Material. The inspection, conducted under the regulatory framework of the Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices, identified nine significant deficiencies.

Key violations included widespread issues with documentation and record-keeping, such as the absence of production equipment usage records and missing temperature logs for intermediate storage during holidays. Process control failures were also noted, including inadequate management of cleaning processes for mixing tank intermediates without proper risk analysis, and unverified changes to intermediate protein content. Furthermore, the company lacked specified protective measures for handling testing instruments and regulations for the periodic calibration of essential equipment like magnetic stirrers and ultrasonic cleaners. Other issues involved insufficient sample retention, a lack of specified temperature monitoring for process water at the point of use, and the absence of regular trend analysis for water for injection test data. Finally, the company had not established procedures for analyzing removed implantable medical devices.

In response, the Shaanxi Provincial Food and Drug Administration has ordered the company to promptly rectify all identified issues, assess product safety risks, and initiate product recalls if safety hazards are found. Follow-up inspections are mandated, and a comprehensive report must be submitted to the State Administration for Market Regulation upon the completion of corrective actions.

Company: https://www.globalkeysolutions.net/companies/shaanxi-ruisheng-biotechnology-co-ltd/cd549749-dc57-4533-9edb-c863af3b404c/