# China NMPA Inspection - Ningbo Tianrun Biopharmaceutical Co., Ltd. - August 01, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/ningbo-tianrun-biopharmaceutical-co-ltd/40b03814-fcac-4f13-955a-f3315f8a5645/
Source feed: China

> China NMPA unannounced inspection for Ningbo Tianrun Biopharmaceutical Co., Ltd. published August 01, 2018. An unannounced inspection of Ningbo Tianrun Biopharmaceutical Co., Ltd. was conducted from July 12 to July 14, 2018, focusing on the manufacturing of 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Ningbo Tianrun Biopharmaceutical Co., Ltd.
- Company Name: Ningbo Tianrun Biopharmaceutical Co., Ltd.
- Publication Date: 2018-08-01
- Product Type: Device
- Summary: An unannounced inspection of Ningbo Tianrun Biopharmaceutical Co., Ltd. was conducted from July 12 to July 14, 2018, focusing on the manufacturing of its Human Rabies Virus IgG Antibody Assay Kit (Enzyme-Linked Immunosorbent Assay). The inspection assessed the company's adherence to the Good Manufacturing Practice for Medical Devices and its specific Appendix for In Vitro Diagnostic Reagents. Several compliance deficiencies were identified. These included a lack of proper labeling for the cold storage temperature alarm system and an inadequate equipment management system that did not confirm calibration results for metrological instruments. Record-keeping issues were also noted, such as missing calculation processes for control standards and absent negative control test results in cleanroom environmental monitoring. Furthermore, the company lacked a robust protocol for operator hand disinfection and failed to verify the effectiveness of its cold storage alarm system. A key finding was the use of an unsubstantiated criterion in the ELISA Positive Reference Standard Calibration procedure. Consequently, the Zhejiang Provincial Food and Drug Administration was directed to mandate the company's prompt rectification, assess product safety risks, initiate recalls if necessary, and conduct follow-up inspections. The provincial authority must report the rectification status to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/ningbo-tianrun-biopharmaceutical-co-ltd/ecd32c68-9ba3-40d4-99d3-1cb6b5727b53/