# China NMPA Inspection - Shandong Zibo Shanchuan Medical Instrument Co. Ltd. - May 23, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/shandong-zibo-shanchuan-medical-instrument-co-ltd/045820d6-3064-4dd3-8167-e333e7da3aca/
Source feed: China

> China NMPA unannounced inspection for Shandong Zibo Shanchuan Medical Instrument Co. Ltd. published May 23, 2016. An unannounced inspection conducted by regulatory authorities, likely under the purview of China's State Food and Drug Administration (SFDA) and Natio

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Shandong Zibo Shanchuan Medical Equipment Co., Ltd.
- Company Name: Shandong Zibo Shanchuan Medical Instrument Co. Ltd.
- Publication Date: 2016-05-23
- Product Type: Device
- Summary: An unannounced inspection conducted by regulatory authorities, likely under the purview of China's State Food and Drug Administration (SFDA) and National Medical Products Administration (NMPA), focused on Shandong Zibo Shanchuan Medical Equipment Co., Ltd. The inspection report, publicly released on May 23, 2016, revealed that the company was in the process of applying for the cancellation of its registration certificate for disposable vacuum blood collection tubes. This discovery was the primary finding, indicating an administrative action initiated by the company rather than a direct manufacturing or compliance violation uncovered during the inspection. Following this, the SFDA instructed the Shandong Provincial Food and Drug Administration to promptly ascertain and confirm the exact status of the company's application for registration cancellation. This event underscores the regulatory framework's role in monitoring the administrative lifecycle of medical device products and ensuring proper oversight of company-initiated product withdrawals within China's healthcare sector.

Company: https://www.globalkeysolutions.net/companies/shandong-zibo-shanchuan-medical-instrument-co-ltd/4721e717-10fc-44f9-8a00-4c95a835d084/