# China NMPA Inspection - Changsha Jingtong Medical Equipment Co., Ltd. - June 04, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/changsha-jingtong-medical-equipment-co-ltd/617e441e-9050-471a-8ceb-a7b9fa3d6793/
Source feed: China

> China NMPA unannounced inspection for Changsha Jingtong Medical Equipment Co., Ltd. published June 04, 2018. An unannounced inspection of Changsha Jingtong Medical Device Co., Ltd., a manufacturer of Customized Removable Dentures, was conducted by the FDA NMP

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Changsha Jingtong Medical Device Co., Ltd.
- Company Name: Changsha Jingtong Medical Equipment Co., Ltd.
- Publication Date: 2018-06-04
- Product Type: Device
- Summary: An unannounced inspection of Changsha Jingtong Medical Device Co., Ltd., a manufacturer of Customized Removable Dentures, was conducted by the FDA NMPA from May 10-11, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices and its appendix for customized dentures, revealed significant non-compliance issues.

Seven serious defects were identified, including the absence of critical equipment like a roughness analyzer and vibrator, essential for product quality and process control. Furthermore, the company failed to maintain accurate and complete material records, did not retain factory inspection reports for raw materials, and improperly mixed different batches of resin dental products. Other serious issues involved a lack of adverse event reporting and missing medical institution qualification certificates.

Additionally, fifteen general deficiencies were noted. These included inadequate insect prevention, a lack of supplier evaluation records, unsafe gas cylinder placement, and using equipment labeled "shut down." Deviations from documented procedures without proper review, incomplete raw material inspection instructions, and poor management of in-process materials were also cited. The company also failed to provide customer complaint handling records, health certificates for operators, and faced contamination risks due to improperly separated production areas. Sterilization processes were found to be deficient, with equipment in dusty zones and a lack of proper records.

Consequently, the Hunan Provincial Food and Drug Administration ordered Changsha Jingtong Medical Device Co., Ltd. to immediately suspend production for rectification. The company must address all identified violations, assess the safety risks of its products, and initiate recalls for any potentially hazardous items, with further legal action to be taken as necessary.

Company: https://www.globalkeysolutions.net/companies/changsha-jingtong-medical-equipment-co-ltd/fa33077f-9725-431f-a18a-18a7bd019fb4/