# China NMPA Inspection - Yangzhou Xiaokang Medical Equipment Co., Ltd. - August 15, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/yangzhou-xiaokang-medical-equipment-co-ltd/eaa89a7a-0175-4399-ac62-8dd3e22c0270/
Source feed: China

> China NMPA unannounced inspection for Yangzhou Xiaokang Medical Equipment Co., Ltd. published August 15, 2018. An unannounced inspection of Hangzhou Kangyou Medical Equipment Co., Ltd. was conducted by the NMPA (via Zhejiang Provincial Food and Drug Administrat

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hangzhou Kangyou Medical Equipment Co., Ltd.
- Company Name: Yangzhou Xiaokang Medical Equipment Co., Ltd.
- Publication Date: 2018-08-15
- Product Type: Device
- Summary: An unannounced inspection of Hangzhou Kangyou Medical Equipment Co., Ltd. was conducted by the NMPA (via Zhejiang Provincial Food and Drug Administration) from July 10-11, 2018. The inspection, based on the "Good Manufacturing Practice for Medical Devices," aimed to assess compliance in the production of their Plasma Coagulation Cutting Blade. The inspection revealed 12 significant deficiencies within the company's quality management system.

Key issues identified included inadequate equipment management, with critical production and testing equipment lacking proper status markings, verification records, and operating procedures. The company also demonstrated poor document control, evident in the use of outdated process flow charts, inconsistent inspection standards, and non-compliant document numbering. Significant problems were found in record keeping, such as unauthorized alterations to environmental logs, discrepancies in material inventory, and unidentifiable shipping tracking numbers. Furthermore, supplier management was deficient, specifically the absence of audit forms for a critical material supplier. Production process controls were incomplete, lacking proper process confirmations, equipment and parameter details in production records, and effective product identification and protection. The company also failed to maintain complete quality inspection records, adhere to sample retention policies, and effectively analyze quality data.

Hangzhou Kangyou Medical Equipment Co., Ltd. is mandated to rectify all identified problems within a specified period. Authorities will conduct necessary follow-up inspections, and the company must assess product safety risks, initiating recalls for any products deemed unsafe. The rectification status must be reported to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/yangzhou-xiaokang-medical-equipment-co-ltd/915199f9-1d76-4de3-8d74-cdcd5fbaca36/