# China NMPA Inspection - Tianjin Yangquan Medical Equipment Co., Ltd. - May 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-yangquan-medical-equipment-co-ltd/bd027ba4-0bb7-4ca7-b60c-9fcedd20c166/
Source feed: China

> China NMPA unannounced inspection for Tianjin Yangquan Medical Equipment Co., Ltd. published May 09, 2018. An unannounced inspection of Tianjin Zhengtian Medical Device Co., Ltd., conducted on April 19-20, 2018, revealed multiple deficiencies in its quality

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Tianjin Zhengtian Medical Equipment Co., Ltd.
- Company Name: Tianjin Yangquan Medical Equipment Co., Ltd.
- Publication Date: 2018-05-09
- Product Type: Device
- Summary: An unannounced inspection of Tianjin Zhengtian Medical Device Co., Ltd., conducted on April 19-20, 2018, revealed multiple deficiencies in its quality management system. The inspection, based on the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Implantable Medical Devices*, identified six general defects impacting product quality and safety, specifically for products like Hip Joint Prosthesis.

Key issues included a lack of clear area markings and management regulations for multi-product packaging in clean production areas. Furthermore, the company failed to effectively maintain its air conditioning system, with filter replacement records indicating no improvement in pressure differential. Document control procedures were found to be incomplete, not encompassing all product types. Significant data integrity problems were observed, with unsigned and undated alterations to manufacturing records and product supply orders. Non-conforming product documentation was also inadequate, missing specific identification details and personnel signatures. Additionally, the company failed to record a critical model number change for a hip joint component and purchased materials not explicitly covered by supplier qualification agreements.

As a result, the Tianjin Municipal Market and Quality Supervision and Management Commission has been directed to order the company to rectify these issues promptly, conduct follow-up inspections, and assess product safety risks. Any products posing safety hazards must be recalled. The Commission is also required to report the company's rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/tianjin-yangquan-medical-equipment-co-ltd/45c4cba3-0cb0-48d5-80c7-9fe7ac578755/