# China NMPA Inspection - Hebei Xinhua Stomatological Technology Co., Ltd. - June 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hebei-xinhua-stomatological-technology-co-ltd/37516708-2751-40b1-97bd-580b13fdc5dd/
Source feed: China

> China NMPA unannounced inspection for Hebei Xinhua Stomatological Technology Co., Ltd. published June 28, 2018. Hebei Xinhua Stomatological Technology Co., Ltd. was subject to an unannounced compliance inspection on June 7, 2018, primarily focused on its product

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hebei Xinhua Stomatological Technology Co., Ltd.
- Company Name: Hebei Xinhua Stomatological Technology Co., Ltd.
- Publication Date: 2018-06-28
- Product Type: Device
- Summary: Hebei Xinhua Stomatological Technology Co., Ltd. was subject to an unannounced compliance inspection on June 7, 2018, primarily focused on its production of Pure Titanium Dental Implants. The inspection was conducted under the regulatory framework of Good Manufacturing Practice for Medical Devices.

The main issues identified during the inspection included a complete absence of personnel and no observable signs of production at the facility. Furthermore, a review of key operational records, such as raw material issuance, usage logs for the water treatment system and testing instruments, and finished product warehousing records, revealed that all entries ceased at the end of 2017. This indicated that no manufacturing activities had taken place for several months prior to the inspection.

As a direct consequence, the company is required to take specific actions before resuming production. Hebei Xinhua Stomatological Technology Co., Ltd. must submit a written report to the Hebei Provincial Food and Drug Administration. Production can only recommence after the provincial administration conducts a subsequent inspection and confirms the company's full compliance. The provincial administration is then obligated to report this resumption of production to the National Medical Products Administration's medical device regulatory department.

Company: https://www.globalkeysolutions.net/companies/hebei-xinhua-stomatological-technology-co-ltd/90c2ed95-0d67-4a58-be22-92c1a8e9fd6c/