# China NMPA Inspection - Hubei Xianming Medical Equipment Co., Ltd. - June 19, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-xianming-medical-equipment-co-ltd/e5b07ced-829c-4241-9101-86ae236569b9/
Source feed: China

> China NMPA unannounced inspection for Hubei Xianming Medical Equipment Co., Ltd. published June 19, 2018. Hubei Xianming Medical Device Co., Ltd. underwent an unannounced compliance inspection from May 23-24, 2018, by the NMPA, focusing on their Disposable

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hubei Xianming Medical Equipment Co., Ltd.
- Company Name: Hubei Xianming Medical Equipment Co., Ltd.
- Publication Date: 2018-06-19
- Product Type: Device
- Summary: Hubei Xianming Medical Device Co., Ltd. underwent an unannounced compliance inspection from May 23-24, 2018, by the NMPA, focusing on their Disposable Bag Infusion Set (with needle). The inspection, based on Good Manufacturing Practices for Medical Devices, revealed significant quality management system deficiencies.

Three serious defects were identified. These included an unreasonable cleanroom layout with personal items in sterile areas, inadequate dust removal, poor sealing, and improper storage of hazardous/substandard products. Furthermore, critical raw materials lacked proper batch numbers, purchase records, or consistency with incoming material reports, indicating traceability issues. The company also failed to verify parameters for recycled material use in key processes like injection molding.

Nine general defects were also cited, encompassing issues such as unmarked piping, incomplete quality management system documentation for raw material ratios, and missing supplier audit records. Other deficiencies included discrepancies between cleaning procedures and validation reports, inadequate cleanroom training, and non-compliance in air purification system operations, monitoring, and validation. Problems with process water documentation, non-adherence to cleaning protocols, and unvalidated storage of intermediate products in clean areas were also found.

Regulatory actions require Hubei Xianming Medical Device Co., Ltd. to immediately suspend production for comprehensive rectification. They must assess product safety risks, recall any hazardous products, and publish their rectification progress. Production resumption is contingent upon rectifying all deficiencies and passing a subsequent inspection. Additionally, the company must apply for an update to its production license and product registration certificate to reflect a changed production address not previously approved for their registered device.

Company: https://www.globalkeysolutions.net/companies/hubei-xianming-medical-equipment-co-ltd/196845cd-6c9c-4380-a159-0021ca2825ff/