# China NMPA Inspection - Suzhou Riyuexing Plastics Co., Ltd. - August 01, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/suzhou-riyuexing-plastics-co-ltd/debd8734-416f-4736-9c10-4d98826f09c5/
Source feed: China

> China NMPA unannounced inspection for Suzhou Riyuexing Plastics Co., Ltd. published August 01, 2018. An unannounced inspection of Suzhou Riyuexing Plastics Co., Ltd., a manufacturer of disposable medical devices such as Suction Kits and Nasal Oxygen T

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Suzhou Riyuexing Plastics Co., Ltd.
- Company Name: Suzhou Riyuexing Plastics Co., Ltd.
- Publication Date: 2018-08-01
- Product Type: Device
- Summary: An unannounced inspection of Suzhou Riyuexing Plastics Co., Ltd., a manufacturer of disposable medical devices such as Suction Kits and Nasal Oxygen Tubes, uncovered serious deficiencies. The initial surprise inspection, conducted by the Jiangsu Provincial Food and Drug Administration from June 28th to 29th, 2018, found significant problems regarding the company's adherence to regulatory standards. These standards include the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*, which define the legal responsibility for establishing and maintaining an effective quality management system.

Following these findings, Suzhou Riyuexing Plastics Co., Ltd. voluntarily halted production for rectification, submitting a written report on July 10, 2018. A follow-up observation on July 12, 2018, confirmed the production halt, with workshops devoid of personnel and equipment. The primary issue was the company's failure to implement and sustain a quality management system suitable for its medical device products.

To resume operations, the company is required to submit a comprehensive written report to the Jiangsu Provincial Food and Drug Administration. Production can only recommence after the Provincial Administration conducts a re-inspection and officially verifies that all identified issues have been rectified and regulatory compliance is achieved. The Provincial Administration must also inform the National Medical Products Administration regarding the company's resumption of production.

Company: https://www.globalkeysolutions.net/companies/suzhou-riyuexing-plastics-co-ltd/e8ee573c-81d5-4afd-a23f-afec84a747c0/