# China NMPA Inspection - Changzhou Ruisos Medical Equipment Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/changzhou-ruisos-medical-equipment-co-ltd/8d2685cf-aec0-48ef-912e-18602d9160d6/
Source feed: China

> China NMPA unannounced inspection for Changzhou Ruisos Medical Equipment Co., Ltd. published August 15, 2018. Changzhou Ruisos Medical Equipment Co., Ltd. was subject to an unannounced inspection on July 24-25, 2018. Based on the Good Manufacturing Practice fo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Changzhou Ruisos Medical Equipment Co., Ltd.
- Company Name: Changzhou Ruisos Medical Equipment Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: Changzhou Ruisos Medical Equipment Co., Ltd. was subject to an unannounced inspection on July 24-25, 2018. Based on the Good Manufacturing Practice for Medical Devices, particularly its sterile medical device appendix, the inspection revealed multiple compliance issues regarding their Disposable Anorectal Anastomosing Device. Significant violations included the absence of temperature and humidity controls in the finished product warehouse and a lack of a designated non-conforming product area. Documentation for personnel entry/exit lacked proper identification, and an obsolete water storage tank was not appropriately marked. Crucially, the company failed to adequately verify the impact of changes made to product components and accepted raw materials that did not meet specifications. Records for ethylene oxide residual content testing were found to be inaccurate, lacking actual temperature data. Additionally, procedures for handling reworked products were incomplete, and the cleanroom air conditioning system was not re-validated after renovation, impacting aseptic processing. Purified water system records were inconsistent, and the sterilization process parameters deviated from validated specifications. Consequently, Changzhou Ruisos Medical Equipment Co., Ltd. is mandated to rectify all identified deficiencies, conduct comprehensive product safety risk assessments, and recall any products deemed unsafe. Follow-up inspections will be conducted, and the Jiangsu Provincial Food and Drug Administration will report rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/changzhou-ruisos-medical-equipment-co-ltd/0622552e-ecee-4047-9e96-1468cb0cbd8c/