In September 2017, the FDA inspectors, Dr. Mark Seaton, Dr. Zhou Chen and Ms. Betsy Galliher conducted a comprehensive and detailed examination on the organization and management, personnel, SOP, experimental facilities, archives, experimental implementation, QA system, computerized system of Medicilon. During the inspection, the FDA inspectors picked a number of research topics to conduct a detailed traceability inspection, of which the inspections were highly praised by the FDA inspectors.
As we all know, FDA is the world’s most stringent audit agencies. It is both an opportunity and challenge for Medicilon if selected by FDA for inspections. In order to pass through the inspections, all of the Medicilon employees were in the best state to response actively with the FDA’s inspections. In terms of expertise, Medicilon has demonstrated the most professional side to the FDA inspectors.
After a week of rigorous inspection, the FDA inspection team concluded and agreed that Medicilon has complied with the US FDA GLP standards with standardized and efficient management system, advanced experimental facilities, excellent staff structure, good QA system, widely used Provantis system and US FDA GLP regulated test data.
Since the establishment in 2004, Medicilon has gained the domestic and international recognition with years of professional services. In 2008, Medicilon and MPI Research established a joint venture company, focusing on preclinical pharmacokinetics and safety evaluation studies. During the JV, Medicilon acquired the AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) certificate, the CFDA GLP certification and comply with US FDA GLP standards.
The successful passing of the on-site inspection by FDA is a further affirmation of the professional services provided by Medicilon. Medicilon will provide a more efficient and cost-effective one-stop professional service to global pharmaceutical communities.