China NMPA Inspection - Sino-British Anokon (Ningxia) Biotechnology Co., Ltd. - October 30, 2018

An unannounced compliance inspection of Zhongying Anuokang (Ningxia) Biotechnology Co., Ltd., conducted by the FDA NMPA on October 19-20, 2018, revealed significant deviations from medical device Good Manufacturing Practices and sterile medical device regulations. The inspection focused on the company's production of Hemostatic Gauze.

Fifteen general defects were identified, highlighting systemic issues across various operational areas. Key violations included inadequate employee training records, disorganized non-conforming material areas, and failure to perform scheduled equipment maintenance. Material management suffered from unstandardized R&D material requisition, inaccurate quantity records, and missing supplier quality documentation. Risk management and supplier qualification processes were deficient, lacking proper signatures, risk analysis for critical processes, and complete audit reports. Production and process control showed weaknesses such as unconfirmed process speeds in validation, incomplete batch production records lacking critical data like weighing equipment numbers and environmental parameters, and insufficient protective measures during semi-finished product transfer and reaction processes. Quality control was compromised by a lack of established process inspection standards, unstandardized aseptic test records, and missing equipment identification in inspection logs. Furthermore, internal audits were found to be ineffective. Specific to sterile production, inconsistencies were noted in water system terminology, discrepancies in sterilization methods recorded versus certified, and inadequate monitoring of purified and water for injection systems.

As a result, the company was ordered to rectify all identified issues within a specified period, assess product safety risks, and recall any potentially hazardous products. Follow-up inspections may be conducted, and a rectification report must be submitted to the National Medical Products Administration.