# China NMPA Inspection - Qingdao Tianyuan Tongtai Trading Company (Limited Partnership) - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/qingdao-tianyuan-tongtai-trading-company-limited-partnership/ab971506-b8ac-45fa-b2c8-66c4a1bbbe71/
Source feed: China

> China NMPA unannounced inspection for Qingdao Tianyuan Tongtai Trading Company (Limited Partnership) published January 10, 2018. An unannounced inspection of Qingdao Tianyuan Tongtai Trading Company (Limited Partnership) in January 2017 revealed significant non-compliance with t

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Qingdao Tianyuan Tongtai Trading Firm (Limited Partnership)
- Company Name: Qingdao Tianyuan Tongtai Trading Company (Limited Partnership)
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: An unannounced inspection of Qingdao Tianyuan Tongtai Trading Company (Limited Partnership) in January 2017 revealed significant non-compliance with the Good Manufacturing Practice for Medical Devices. The company, authorized for a broad scope of Class II and III medical devices, including implantable materials, faced eight identified deficiencies, four of which were critical. Key issues included a faulty self-inspection system that omitted annual report submissions to regulators and inadequate record-keeping for incoming goods, particularly lacking permanent retention policies for implantable devices. A critical personnel deficiency was noted, with no employees holding medical-related degrees or manufacturer training for implantable products, despite operating in that area. Furthermore, the company's computer system lacked essential functions for verifying supplier legality and validity. General defects involved incomplete training records, insufficient professional medical device knowledge in training plans, and the absence of a health certificate for a salesperson. The warehouse also lacked proper storage areas for packaging materials and facilities for returned items. Additionally, the company could not provide purchasing records from its only stated client. Qingdao Tianyuan Tongtai is required to address these systemic and operational deficiencies to ensure adherence to medical device regulatory standards.

Company: https://www.globalkeysolutions.net/companies/qingdao-tianyuan-tongtai-trading-company-limited-partnership/e85baa69-5ca6-43b6-b72a-f61843d8d9b9/