# China NMPA Inspection - Xinxiang Huaxi Medical Supplies Co., Ltd. - July 16, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/xinxiang-huaxi-medical-supplies-co-ltd/07595868-6f21-4a56-a97d-8aa259e6e676/
Source feed: China

> China NMPA unannounced inspection for Xinxiang Huaxi Medical Supplies Co., Ltd. published July 16, 2018. Xinxiang Huaxi Medical Supplies Co., Ltd. underwent an unannounced inspection from June 28-29, 2018, based on the Good Manufacturing Practice for Medi

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Xinxiang Huaxi Medical Supplies Co., Ltd.
- Company Name: Xinxiang Huaxi Medical Supplies Co., Ltd.
- Publication Date: 2018-07-16
- Product Type: Device
- Summary: Xinxiang Huaxi Medical Supplies Co., Ltd. underwent an unannounced inspection from June 28-29, 2018, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices. The inspection revealed eight general deficiencies, primarily related to inadequate documentation and quality control systems. 

Key issues included operating procedures for printing and sealing machines lacking specific parameters for different products, and outdated or inconsistent standards cited in microorganism testing procedures. The company also had significant documentation control problems, with multiple conflicting versions of procedures and inconsistent document numbering. Supplier re-evaluation forms were found incomplete, and material names and specifications for components like mask straps were inconsistent across various internal documents and production records.

Further deficiencies were identified in laboratory management, where chemical reagents and microbiology cultures were found unlabeled. The finished product warehouse lacked proper location cards. The company also failed to maintain sufficient retained product samples to allow for full performance testing, and actual sample quantities did not match records. Lastly, sterilization records for medical surgical masks were incomplete, with inconsistent batch number formats and missing ethylene oxide dosage information.

The Henan Provincial Food and Drug Administration mandated the company to rectify all identified issues within a specified period. This includes assessing product safety risks, potentially recalling hazardous products, and reporting all corrective actions to the National Medical Products Administration. Follow-up inspections may be conducted to ensure compliance.

Company: https://www.globalkeysolutions.net/companies/xinxiang-huaxi-medical-supplies-co-ltd/58c01494-7dcb-4cd8-aa4b-7df2597c9f13/