# China NMPA Inspection - Hainan Taihe Medical Technology Co., Ltd. - June 04, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hainan-taihe-medical-technology-co-ltd/03a7176e-040c-40ce-bd08-b0aa2f05a102/
Source feed: China

> China NMPA unannounced inspection for Hainan Taihe Medical Technology Co., Ltd. published June 04, 2018. Hainan Taihe Medical Technology Co., Ltd. underwent an unannounced compliance inspection from May 9-10, 2018, based on the Good Manufacturing Practice

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hainan Taihe Medical Technology Co., Ltd.
- Company Name: Hainan Taihe Medical Technology Co., Ltd.
- Publication Date: 2018-06-04
- Product Type: Device
- Summary: Hainan Taihe Medical Technology Co., Ltd. underwent an unannounced compliance inspection from May 9-10, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection revealed significant deficiencies in their quality management system for Rotary Magnetic Diabetes Treatment Instruments.

Key violations included an untrained management representative reviewing inspection reports, absence of purchase records for main unit casings, lack of supplier qualification certificates for various components, and missing batch production records corresponding to worker workload. Furthermore, product factory inspection reports showed inconsistencies with established procedures, specifically lacking a critical "Work Condition Inspection" item.

Minor issues identified encompassed sharing a production area with a food facility, inadequate storage conditions lacking temperature/humidity control and records, insufficient documentation for equipment use and maintenance, absence of retained sample observation records, and a failure to establish a preventative action procedure or conduct customer surveys.

As a result, the company was ordered to immediately suspend production for comprehensive rectification. They are required to analyze defect causes, assess product safety risks, and recall any potentially hazardous products. Production can only resume after all deficiencies are rectified and a successful follow-up inspection is completed by the Provincial Administration. Legal action will be pursued for all identified violations.

Company: https://www.globalkeysolutions.net/companies/hainan-taihe-medical-technology-co-ltd/e0715a0e-b6dd-4da0-97db-73bdf5d33aa1/