# China NMPA Inspection - Qinghai Ruilang Medical Technology Development Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/qinghai-ruilang-medical-technology-development-co-ltd/8ea07c6a-c2f2-4a09-a80d-41c5c4614aef/
Source feed: China

> China NMPA unannounced inspection for Qinghai Ruilang Medical Technology Development Co., Ltd. published August 15, 2018. An unannounced inspection by regulatory authorities on July 26, 2018, targeted Qinghai Ruilang Medical Technology Development Co., Ltd. The inspection

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Qinghai Ruilang Medical Technology Development Co., Ltd.
- Company Name: Qinghai Ruilang Medical Technology Development Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: devices
- Summary: An unannounced inspection by regulatory authorities on July 26, 2018, targeted Qinghai Ruilang Medical Technology Development Co., Ltd. The inspection, which focused on compliance with Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices, revealed critical issues. Investigators found the production workshop to be shut down, with no raw materials in storage and no finished products present. The company had not organized any production activities since obtaining its registration certificate for the Disposable Bacterial Filter. Consequently, Qinghai Ruilang Medical Technology Development Co., Ltd. is required to submit a written report to the Qinghai Provincial Food and Drug Administration before any manufacturing can resume. Production can only recommence after the Qinghai Provincial Administration conducts a follow-up inspection and confirms that the company meets all necessary requirements. The Qinghai Provincial Food and Drug Administration must then promptly report the resumption of production to the National Medical Products Administration's medical device regulatory department.

Company: https://www.globalkeysolutions.net/companies/qinghai-ruilang-medical-technology-development-co-ltd/a3736f45-303f-460c-af3f-eac72090794a/