# China NMPA Inspection - Gansu Baixin Science & Industry Trade Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/gansu-baixin-science-industry-trade-co-ltd/163779de-7b02-408e-8639-2e5db8847a40/
Source feed: China

> China NMPA unannounced inspection for Gansu Baixin Science & Industry Trade Co., Ltd. published January 09, 2018. Gansu Baixin Science & Technology Industry & Trade Co., Ltd. was subject to an unannounced compliance inspection on November 20, 2017. The inspection,

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Gansu Baixin Science, Industry and Trade Co., Ltd.
- Company Name: Gansu Baixin Science & Industry Trade Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: Gansu Baixin Science & Technology Industry & Trade Co., Ltd. was subject to an unannounced compliance inspection on November 20, 2017. The inspection, based on the "Good Manufacturing Practice for Medical Devices" framework, revealed three general deficiencies in the company's operations.

Key issues included inadequate training documentation, as no records were found for the 2017 continuing education plan, and computer system operators demonstrated a lack of familiarity with the system. Furthermore, employee health records were incomplete, specifically missing health check records for 2016. Warehouse management also presented a problem, with qualified products being improperly stored in the designated return area, despite the presence of distinct sections.

In response to these findings, the Gansu Provincial Food and Drug Administration is mandated to instruct Gansu Baixin Science & Technology Industry & Trade Co., Ltd. to address and correct these issues within a defined period. The administration must then conduct follow-up inspections to verify rectification. Once the company achieves compliance, the relevant details must be promptly communicated to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/gansu-baixin-science-industry-trade-co-ltd/87f3f9b0-b77f-47c5-b427-034040999bba/