The National Drug Administration recently organized a remote inspection of French PIERRE FABRE MEDICAMENT Encofini capsules. After investigation, major changes in the production process of the active ingredient encofinil indicated in the registration information for this formulation have not been approved. The company used the active ingredient in batch production and marketing for sale to the Chinese market. There was a serious deviation between the change control and release review of the quality management system and the pharmaceutical production quality management standards, which did not meet the requirements of China's “Pharmaceutical Production Quality Management Code” and appendices. According to relevant regulations such as Article 99 of the “Drug Administration Law of the People's Republic of China” and Article 30 of the “Regulations on the Administration of Overseas Inspection of Drugs and Medical Devices”, the State Drug Administration decided to suspend the sale and use of PIERRE FABRE MEDICAMENT Encofini capsules with batch numbers 5G2T3 and 5G2T4 from now on.

The National Drug Administration recently organized a remote inspection of French PIERRE FABRE MEDICAMENT Encofini capsules. After investigation, major changes in the production process of the active ingredient encofinil indicated in the registration information for this formulation have not been approved. The company used the active ingredient in batch production and marketing for sale to the Chinese market. There was a serious deviation between the change control and release review of the quality management system and the pharmaceutical production quality management standards, which did not meet the requirements of China's “Pharmaceutical Production Quality Management Code” and appendices. According to relevant regulations such as Article 99 of the “Drug Administration Law of the People's Republic of China” and Article 30 of the “Regulations on the Administration of Overseas Inspection of Drugs and Medical Devices”, the State Drug Administration decided to suspend the sale and use of PIERRE FABRE MEDICAMENT Encofini capsules with batch numbers 5G2T3 and 5G2T4 from now on.