# China NMPA Inspection - Jiangsu Hengkang Medical Equipment Co., Ltd. - December 12, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-hengkang-medical-equipment-co-ltd/f928ccc6-dd7c-43bd-bb81-9cacad7befa6/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Hengkang Medical Equipment Co., Ltd. published December 12, 2018. On December 5, 2018, the National Medical Products Administration (NMPA) announced findings from a recent surprise inspection of Jiangsu Hengkang Medi

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement Regarding the Suspension of Production and Rectification of Jiangsu Hengkang Medical Equipment Co., Ltd. (No. 125 of 2018)
- Company Name: Jiangsu Hengkang Medical Equipment Co., Ltd.
- Publication Date: 2018-12-12
- Product Type: Device
- Summary: On December 5, 2018, the National Medical Products Administration (NMPA) announced findings from a recent surprise inspection of Jiangsu Hengkang Medical Equipment Co., Ltd. The inspection revealed significant deficiencies in the company's quality management system, indicating serious non-compliance with the *Good Manufacturing Practice for Medical Devices* (GMP).

Key violations included the company's failure in procurement to establish quality agreements with its main raw material supplier, medical PVC granules, as required by GMP Article 42. In quality control, critical sterile, microbial limit, and positive control rooms shared an air conditioning and purification system, as well as a pass-through window, with clean production areas. Furthermore, a leak was identified in a high-efficiency filter within a cleanroom, compromising environmental integrity. The NMPA also cited issues in non-conforming product control, where compliant and non-compliant products were mixed without proper labeling or isolation, and no records of non-conforming product disposal were maintained, violating GMP Article 68.

As a result, the NMPA, through the Jiangsu Provincial Medical Products Administration, ordered Jiangsu Hengkang Medical Equipment Co., Ltd. to immediately cease production and undertake comprehensive rectification. The company must also assess product safety risks and initiate recalls for any potentially hazardous products, adhering to the *Measures for the Administration of Medical Device Recalls*. Production can only resume after all deficiencies are fully addressed and a subsequent inspection by the provincial regulatory authority confirms compliance. The NMPA emphasized that violations of the *Regulations on the Supervision and Administration of Medical Devices* and related laws would face serious legal consequences.

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