# China NMPA Inspection - Xiamen Anpuli Biotechnology Co., Ltd. - August 01, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/xiamen-anpuli-biotechnology-co-ltd/80894528-9b21-4d88-9509-a8f1efd58a23/
Source feed: China

> China NMPA unannounced inspection for Xiamen Anpuli Biotechnology Co., Ltd. published August 01, 2018. An unannounced inspection of Xiamen Anpuli Biotechnology Co., Ltd. by the NMPA on July 10-11, 2018, revealed significant deficiencies in its quality m

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Xiamen Anpuli Biotechnology Co., Ltd.
- Company Name: Xiamen Anpuli Biotechnology Co., Ltd.
- Publication Date: 2018-08-01
- Product Type: Device
- Summary: An unannounced inspection of Xiamen Anpuli Biotechnology Co., Ltd. by the NMPA on July 10-11, 2018, revealed significant deficiencies in its quality management system, particularly concerning the production of its Hepatitis C Virus Nucleic Acid Detection Kit. The inspection, based on the Good Manufacturing Practice for Medical Devices and its In Vitro Diagnostic Reagents Appendix, identified multiple non-conformities across several critical areas. Key violations included inadequate control over raw materials, with missing expiration dates and opening identifications. Calibration procedures and records for measuring instruments were found to be deficient, lacking confirmation results and proper documentation, while some equipment was overdue for calibration. The company also demonstrated inconsistencies in document control, with multiple versions of the same SOPs and discrepancies between production records, design outputs, and quality standards for reference materials. Furthermore, there were errors in concentration calculations and incomplete validation of critical testing methods, such as DNase/RNase activity and negative serum screening. Cleanroom management also exhibited significant flaws, including unvalidated hand disinfection agents, incorrect colony count limits for garment cleaning, and inadequate monitoring and maintenance protocols for air cleanliness and purified water systems. As a result, the Fujian Provincial Food and Drug Administration was directed to mandate the company's rectification of these issues within a defined timeframe. This includes assessing product safety risks, potentially recalling unsafe products, and undergoing follow-up inspections. The provincial administration must then report the rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/xiamen-anpuli-biotechnology-co-ltd/180d35dc-6aae-488a-b491-2160dbeb81ce/