# China NMPA Inspection - Henan Tiger Medical Equipment Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/henan-tiger-medical-equipment-co-ltd/08e70bdc-10da-416a-994e-7230c3c2e5a5/
Source feed: China

> China NMPA unannounced inspection for Henan Tiger Medical Equipment Co., Ltd. published January 09, 2018. An unannounced inspection conducted in January 2017 by regulatory authorities identified significant compliance deficiencies at Henan Tiger Medical De

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Henan Tiger Medical Devices Co., Ltd.
- Company Name: Henan Tiger Medical Equipment Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection conducted in January 2017 by regulatory authorities identified significant compliance deficiencies at Henan Tiger Medical Devices Co., Ltd., under the framework of Good Manufacturing Practice for Medical Devices. The inspection revealed 18 defects, including 8 critical and 10 general issues, highlighting systemic failures in the company's quality management system. Key violations included a failure to identify product risks and implement appropriate quality controls. The company's quality manager, Mr. Huang (who joined in March 2017), was found to lack independent job ability, and his responsibilities were being handled by the company head. Furthermore, Mr. Huang did not meet the required experience for his role and lacked familiarity with critical areas like adverse event handling. The legal representative also demonstrated insufficient knowledge of medical device regulations. Significant record-keeping and procedural gaps were identified, such as the absence of a comprehensive quality management system covering all operations, lack of product traceability, and missing records for equipment maintenance, calibration, incoming goods acceptance, and supplier reviews. The company failed to provide accompanying delivery slips, establish acceptance and purchaser records, or maintain proper sales and outbound verification records. Warehouse management was also cited for inadequate segregation of medical and non-medical devices and improper labeling. As a result, the Henan Provincial Food and Drug Administration is mandated to order Henan Tiger Medical Devices Co., Ltd. to rectify these issues within a defined timeframe. Follow-up inspections are required, and the findings, along with rectification progress, must be reported to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/henan-tiger-medical-equipment-co-ltd/23cdfa43-206c-4cd8-a109-ee25204b9744/