# China NMPA Inspection - Tianjin Yangquan Medical Equipment Co., Ltd. - June 23, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-yangquan-medical-equipment-co-ltd/d94a6798-af07-4424-ad5a-d869001b2ec3/
Source feed: China

> China NMPA unannounced inspection for Tianjin Yangquan Medical Equipment Co., Ltd. published June 23, 2017. The State Food and Drug Administration (SFDA) announced on June 23, 2017, an unannounced inspection of Tianjin Yangquan Medical Device Co., Ltd., reve

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 95 of 2017 from the State Administration for Market Regulation regarding the suspension of production and rectification of Tianjin Yangquan Medical Device Co., Ltd.
- Company Name: Tianjin Yangquan Medical Equipment Co., Ltd.
- Publication Date: 2017-06-23
- Product Type: devices
- Summary: The State Food and Drug Administration (SFDA) announced on June 23, 2017, an unannounced inspection of Tianjin Yangquan Medical Device Co., Ltd., revealing serious non-compliance with medical device regulations and significant deficiencies in its quality management system, particularly concerning Good Manufacturing Practice (GMP) for Medical Devices. Key issues included discrepancies in licensed production locations and an outdated medical device registration certificate. Specific violations comprised inadequate hazardous materials storage at both production sites and significant traceability failures in procurement, with unrecorded materials and discrepancies between purchased and requisitioned resin. Production management deficiencies involved incomplete batch records for disposable blood perfusion devices, lacking critical information, and deviations from established sterilization procedures, including the use of an unauthorized sterilizer and improper product transfer. Quality control weaknesses highlighted expired testing equipment in the laboratory without current calibration certificates, and insufficient testing evidence for both finished products and raw materials against specified standards. Furthermore, internal audit records were incomplete, indicating a systemic failure in adverse event monitoring and improvement processes. Consequently, Tianjin Yangquan Medical Device Co., Ltd. was ordered to immediately cease production and undertake comprehensive rectification. The company must also assess product safety risks and recall any potentially hazardous products in accordance with recall regulations. Production resumption is contingent upon successful completion of all corrective actions and passing a subsequent inspection by the provincial food and drug administration, with further legal action pending for violations of medical device supervision and administration regulations.

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