Inspection report of Jiangxi Meilin Kangda Pharmaceutical in China was recently issued by the National Medical Products Administration (NMPA) on July 19, 2023. Key concerns about the company’s quality management system were reported.
Manufacturers and related businesses in the medical device industry should understand the critical importance of adhering to China regulatory standards to ensure public health and safety. In this blog post, we delve into the findings of the inspection and highlight the crucial role of compliance in medical device production.
Facility and Equipment Management
During the inspection, the NMPA identified certain deficiencies in the quality management system of Jiangxi Melin Kangda Pharmaceutical. The inspection revealed that the company’s environment contained an interconnected epoxy ethane sterilization room and analysis room, lacking any physical segregation. This raised concerns about potential cross-contamination risks, a violation of the “Regulations on Quality Management of Medical Device Production” and the “Appendix on Aseptic Medical Devices” (referred to as the “Regulations” and “Aseptic Appendix”). The regulations mandate that facilities and equipment be designed, laid out, and utilized reasonably, considering the characteristics of the products being manufactured and their corresponding cleanliness requirements.
Design and Development
Another major concern identified by the NMPA was the company’s use of non-woven fabric from a new supplier, which did not conform to the quality inspection standards applied by the original supplier. Additionally, no relevant validation was conducted for this change, contravening the “Regulations” and “Aseptic Appendix.” The “Regulations” require companies to assess any modifications in materials, components, or product functionalities, as they may impact the safety and effectiveness of medical devices. It is imperative to evaluate potential risks and adopt necessary measures while ensuring compliance with relevant regulations.
Implications and NMPA’s actions
Given the severity of the identified deficiencies, Jiangxi Melinkang Pharmaceutical has acknowledged the issues within its quality management system. The NMPA, in accordance with Article 72 of the “Regulations on the Supervision and Administration of Medical Devices,” has taken stringent actions. The Jiangxi Provincial Drug Administration will enforce control measures, including suspending production, to address the non-compliance effectively. Furthermore, any violations of the “Regulations on the Supervision and Administration of Medical Devices” and related provisions will be addressed in accordance with the law. The company is also required to conduct an assessment of product safety risks and, if necessary, initiate a product recall as per the “Management Measures for Medical Device Recalls.”
Read the original NMPA announcement on inspection of Jiangxi Meilin Kangda Pharmaceutical.
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