# China NMPA Inspection - Guangzhou Hepule Health Technology Co., Ltd. - June 30, 2021

Source: https://www.globalkeysolutions.net/records/china_inspection/guangzhou-hepule-health-technology-co-ltd/7bc406e5-a5a2-4423-a149-47632489c1ad/
Source feed: China

> China NMPA unannounced inspection for Guangzhou Hepule Health Technology Co., Ltd. published June 30, 2021. The National Medical Products Administration (NMPA) conducted a surprise inspection of Guangzhou Hepule Health Technology Co., Ltd., with findings ann

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 43 of 2021 from the National Medical Products Administration regarding the inspection of Guangzhou Hepu Health Technology Co., Ltd.
- Company Name: Guangzhou Hepule Health Technology Co., Ltd.
- Publication Date: 2021-06-30
- Product Type: devices
- Summary: The National Medical Products Administration (NMPA) conducted a surprise inspection of Guangzhou Hepule Health Technology Co., Ltd., with findings announced on June 30, 2021. The inspection revealed serious deficiencies in the company's quality management system, failing to comply with the Good Manufacturing Practice for Medical Devices.

Key violations included issues in production management, such as incomplete work instructions for the critical 'dynamic balancing' process lacking specific parameter regulations. Discrepancies were also noted in batch records for the '8-series positive pressure ventilation therapy machine,' involving inconsistent main control board PCBA disposal, production process documentation, and aging unit quantities.

Quality control failures included not using specified connectors (YY/T1040.1-2015) for continuous positive pressure ventilators and a lack of connection firmness testing. Batch inspection records were deficient, missing original data for pressure error inspections, static pressure stability, maximum gas flow rates, and proper documentation of testing instruments or parameter adjustments.

Furthermore, in adverse event monitoring, the company failed to analyze all sold products with the same batch number during a recall investigation.

As a result, the Guangdong Provincial Drug Administration has ordered Guangzhou Hepule Health Technology Co., Ltd. to immediately cease production for rectification. The company must address all deficiencies, assess product safety risks, recall any hazardous products, and will only be permitted to resume production after completing rectification and passing a re-inspection.

Company: https://www.globalkeysolutions.net/companies/guangzhou-hepule-health-technology-co-ltd/1f363771-a579-4a7c-8f99-37581bf527d2/