# China NMPA Inspection - Hebei Huiren Medical Equipment Technology Co., Ltd. - December 07, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hebei-huiren-medical-equipment-technology-co-ltd/dd320594-0244-426d-9d80-41d1452cb77b/
Source feed: China

> China NMPA unannounced inspection for Hebei Huiren Medical Equipment Technology Co., Ltd. published December 07, 2017. An unannounced inspection of Hebei Huiren Medical Equipment Technology Co., Ltd., conducted from November 20-22, 2017, revealed eight general complian

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hebei Huiren Medical Equipment Technology Co., Ltd.
- Company Name: Hebei Huiren Medical Equipment Technology Co., Ltd.
- Publication Date: 2017-12-07
- Product Type: Device
- Summary: An unannounced inspection of Hebei Huiren Medical Equipment Technology Co., Ltd., conducted from November 20-22, 2017, revealed eight general compliance deficiencies related to the company's Good Manufacturing Practice for Medical Devices. The inspection focused on the production of Conventional Conductive Magnetic Resonance Imaging Systems.Key issues included a lack of appropriate academic qualifications for the Production Manager and improper storage of testing equipment within raw material areas. Significant procedural lapses were identified in document control, with unauthorized changes made to manufacturing instructions and outdated procedures for product batch numbering. Procurement processes were found deficient, lacking supplier inspection reports for critical materials and containing inaccuracies in material identification and receiving documentation. Furthermore, the company failed to provide calibration records for essential monitoring equipment.Critically, the inspection highlighted inadequate post-market surveillance and risk management. Customer feedback indicated repeat failures of RF power amplifiers without proper root cause analysis, risk assessment, or effective preventative actions to avoid recurrence.As a result, the company has been ordered by the Hebei Provincial Food and Drug Administration to rectify all identified issues within a specified timeframe. Hebei Huiren Medical Equipment Technology Co., Ltd. must also assess product safety risks, potentially initiating recalls for any products deemed hazardous. Follow-up inspections will be conducted, and a report on the rectification efforts will be submitted to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/hebei-huiren-medical-equipment-technology-co-ltd/d4feed3a-89fa-4d0f-84be-c8beea38005d/