# China NMPA Inspection - Jiangsu Hengkang Medical Equipment Co., Ltd. - July 14, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-hengkang-medical-equipment-co-ltd/eec1b183-375d-4ecf-a48e-80f8940e61ac/
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> China NMPA unannounced inspection for Jiangsu Hengkang Medical Equipment Co., Ltd. published July 14, 2017. An unannounced inspection conducted by the State Food and Drug Administration (SFDA) between June 20-22, 2017, identified multiple compliance deficien

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notice from the General Office of the State Administration of Radio and Television on Urging Zhejiang KangKang Medical Device Co., Ltd. to Rectify Problems Found During Unannounced Inspections
- Company Name: Jiangsu Hengkang Medical Equipment Co., Ltd.
- Publication Date: 2017-07-14
- Product Type: Device
- Summary: An unannounced inspection conducted by the State Food and Drug Administration (SFDA) between June 20-22, 2017, identified multiple compliance deficiencies at Zhejiang KangKang Medical Device Co., Ltd. The inspection, based on the "Good Manufacturing Practice for Medical Devices" and its appendix for "Sterile Medical Devices," revealed significant issues across several operational areas. Key violations included a lack of valid health certificates for some employees in critical production areas and inadequate environmental controls, such as high temperature and humidity in the finished product warehouse and insufficient ventilation. The company also failed to properly validate equipment, with the automatic syringe assembly machine's validation report missing operating parameters and test results. Furthermore, documentation deficiencies were noted in sealing records, design and development procedures, and the absence of acceptance criteria for raw material procurement. Production and sales records also lacked essential information, such as specific dryer numbers and complete customer contact details. The Zhejiang Provincial Food and Drug Administration has been instructed to mandate timely rectification by Zhejiang KangKang Medical Device Co., Ltd., including follow-up inspections to assess product safety risks and potential recalls if necessary. The company must report its corrective actions to the SFDA. Additionally, the provincial authority is required to enhance daily supervision, increase inspection frequency for problematic companies, and ensure strict adherence to quality management responsibilities to uphold product safety and effectiveness.

Company: https://www.globalkeysolutions.net/companies/jiangsu-hengkang-medical-equipment-co-ltd/dffe9087-59e1-41b3-8d55-5d37c2348f0e/