# China NMPA Inspection - Hebei Mingjia Medical Equipment Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hebei-mingjia-medical-equipment-co-ltd/25cf422c-1e09-4d79-87fb-0d0ed537c443/
Source feed: China

> China NMPA unannounced inspection for Hebei Mingjia Medical Equipment Co., Ltd. published January 09, 2018. Hebei Mingjia Medical Equipment Co., Ltd. was subjected to an unannounced compliance inspection by the NMPA from November 20-21, 2017, under the frame

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hebei Mingjia Medical Equipment Co., Ltd.
- Company Name: Hebei Mingjia Medical Equipment Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: Hebei Mingjia Medical Equipment Co., Ltd. was subjected to an unannounced compliance inspection by the NMPA from November 20-21, 2017, under the framework of the "Good Manufacturing Practice for Medical Devices." The inspection uncovered 12 significant deficiencies, comprising 4 critical and 8 general issues, highlighting widespread non-compliance with regulatory standards.

Key critical violations included the absence of a designated quality management department and the ineffective execution of duties by quality management personnel. The company failed to produce a cold storage validation plan and report. Crucially, Hebei Mingjia sold regulated medical devices, such as a scanning glucose monitoring system and an implantable pacemaker, without verifying the purchasing entities' required qualifications, violating essential distribution and traceability protocols. Sales records were also incomplete, lacking vital manufacturer and product registration information.

General findings included uncalibrated warehouse temperature and humidity meters, inaccurate annual quality self-inspection reports, and an insufficient purchase and acceptance system that failed to specify shelf-life for implantable products. Personnel lacked appropriate qualifications or training documentation, and regulatory knowledge was deficient among key staff. Furthermore, proper segregation and documentation of non-conforming products were not maintained, and sales contracts were found to be incomplete.

As a consequence, the Hebei Provincial Food and Drug Administration has mandated Hebei Mingjia Medical Equipment Co., Ltd. to rectify these identified issues within a specified period, with subsequent follow-up inspections and reporting to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/hebei-mingjia-medical-equipment-co-ltd/796dbaec-3ff4-481a-bb62-4c43e3dd9b4b/