# China NMPA Inspection - Luoyang Meihua Rensheng Medical Equipment Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/luoyang-meihua-rensheng-medical-equipment-co-ltd/d74813a1-ad79-451f-bc25-6ca9f5a3ec37/
Source feed: China

> China NMPA unannounced inspection for Luoyang Meihua Rensheng Medical Equipment Co., Ltd. published January 09, 2018. An unannounced inspection of Luoyang Meihua Rensheng Medical Equipment Co., Ltd. was conducted by the FDA NMPA from November 22nd to November 23rd, 20

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Luoyang Meihua Rensheng Medical Equipment Co., Ltd.
- Company Name: Luoyang Meihua Rensheng Medical Equipment Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection of Luoyang Meihua Rensheng Medical Equipment Co., Ltd. was conducted by the FDA NMPA from November 22nd to November 23rd, 2017. Based on the Good Manufacturing Practice for Medical Devices, the inspection revealed 29 deficiencies, comprising 10 critical and 19 general issues.

Key violations indicated a significant breakdown in the company's quality management system. The company failed to provide adequate office conditions for its quality organization, and the quality manager was absent, unable to fulfill responsibilities. There was no evidence of an effectively operating quality management system, and the legal representative lacked knowledge of relevant medical device regulations. Personnel qualifications were unverifiable, and essential after-sales service personnel and conditions were absent. Operational shortcomings included unsuitable business premises and retail facilities for the company's scope, improper storage with mixed medical and non-medical devices, and a lack of regular inventory inspections or expired product management. Crucially, the company lacked comprehensive documentation, including supplier and purchaser files, purchase, sales, and acceptance records, and agreements for quality and after-sales responsibilities. To address these findings, Luoyang Meihua Rensheng Medical Equipment Co., Ltd. is required to establish and maintain a suitable and effective quality management system, ensure personnel competence, implement thorough record-keeping, and achieve full compliance with medical device Good Manufacturing Practice across all operations.

Company: https://www.globalkeysolutions.net/companies/luoyang-meihua-rensheng-medical-equipment-co-ltd/28e27916-a84d-4ecc-863d-963ea7c8deb5/