From June 2nd to June 6th, 2020, the Food and Drug Inspection Center of the National Medical Products Administration appointed Jiangsu Provincial Drug Administration to conduct on-site registration inspections and GMP compliance of our API (cyclosporine) examine. This inspection involves our company's safety management, verification management, process and production, quality inspection, quality management and material management.

The inspection team inspected the bacterial strains, fermentation, extraction, fine drying contracting sections of the production workshop, purified water system, storage, testing center, etc., and checked relevant documents, records, ledgers and other information. Key inspections were conducted on quality control, verification management, change control, deviation management, quality risk management, and quality control measures.

After 5 days of inspection, the inspection team raised general deficiencies in our company’s production management, safety management, etc., and fully recognized our company’s drug quality management system, confirmed that it complies with the requirements of the 2010 version of the drug production quality management specification, and encourages us Continue to improve its own quality management level to make it more in line with GMP requirements, and at the same time positively affirm our company's normalized management of drug quality as a social responsibility.