# China NMPA Inspection - Henan Tuoren Blood Filtration Medical Equipment Co., Ltd. - August 10, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/henan-tuoren-blood-filtration-medical-equipment-co-ltd/e682ad1f-44c5-42b8-b1b1-93a75c01964f/
Source feed: China

> China NMPA unannounced inspection for Henan Tuoren Blood Filtration Medical Equipment Co., Ltd. published August 10, 2017. An unannounced inspection of Henan Tuoren Blood Filtration Medical Device Co., Ltd. was conducted from July 20-22, 2017, to assess compliance with Goo

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Henan Tuoren Blood Filter Medical Device Co., Ltd.
- Company Name: Henan Tuoren Blood Filtration Medical Equipment Co., Ltd.
- Publication Date: 2017-08-10
- Product Type: Device
- Summary: An unannounced inspection of Henan Tuoren Blood Filtration Medical Device Co., Ltd. was conducted from July 20-22, 2017, to assess compliance with Good Manufacturing Practice for Medical Devices, including specific requirements for Sterile Medical Devices. The inspection revealed significant quality system deficiencies related to the company's extracorporeal circulation blood circuit products. Key violations included severe issues with batch production record traceability, such as undisclosed production batches, discrepancies between documented and actual production quantities, and inconsistent batch records. The company also failed to properly label the inspection status of semi-finished products, creating a risk of unqualified items advancing in the production process. Additionally, a critical ethylene oxide sterilizer (Sterilizer B) used for product sterilization lacked proper verification, and its operational parameters did not align with documented instructions. General deficiencies encompassed a lack of effective quality system oversight, an unclean and inadequately isolated production environment, insufficient material storage management, and discrepancies in reported product test data. Other issues included inadequate cleanroom pressure differentials, ineffective material transfer mechanisms, and poor management of process water and compressed air purity. Consequently, the company has been ordered to immediately suspend production for comprehensive rectification, assess product safety risks, and address all identified regulatory non-conformities.

Company: https://www.globalkeysolutions.net/companies/henan-tuoren-blood-filtration-medical-equipment-co-ltd/05f5b116-b1e3-469f-a7fd-191298cca60e/