# China NMPA Inspection - Guangxi Pharmaceutical Technology Medical Supplies Factory - October 30, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guangxi-pharmaceutical-technology-medical-supplies-factory/3f8718dc-63cd-4a80-8fcc-2f54711eec0b/
Source feed: China

> China NMPA unannounced inspection for Guangxi Pharmaceutical Technology Medical Supplies Factory published October 30, 2018. An unannounced inspection of Guangxi Pharmaceutical Technology Medical Supplies Factory took place on October 18, 2018. The inspection, categorized as

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangxi Pharmaceutical Technology Medical Supplies Factory
- Company Name: Guangxi Pharmaceutical Technology Medical Supplies Factory
- Publication Date: 2018-10-30
- Product Type: Device
- Summary: An unannounced inspection of Guangxi Pharmaceutical Technology Medical Supplies Factory took place on October 18, 2018. The inspection, categorized as a compliance review, was conducted under the regulatory framework of the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices. The primary objective was to verify the company's operational status following previously reported production stoppages.

The factory had officially submitted production stoppage reports to regulatory bodies on May 3, 2016, and September 26, 2016. During the 2018 inspection, authorities confirmed that the company had not resumed production of its Disposable Infusion Set with Needle since these declarations. No new violations or specific manufacturing defects during active production were identified, as the facility was not operational.

As a result, the regulatory body has mandated that Guangxi Pharmaceutical Technology Medical Supplies Factory is prohibited from resuming production until it undergoes and successfully passes a subsequent inspection by the Guangxi Zhuang Autonomous Region Food and Drug Administration. This ensures adherence to quality and safety standards before any manufacturing activities can recommence.

Company: https://www.globalkeysolutions.net/companies/guangxi-pharmaceutical-technology-medical-supplies-factory/a007c063-566a-4efb-a326-2ea79fdcc2e9/