On July 16th, Gelonghui reported that Porton Pharma Solutions (300363.SZ) announced that its Chongqing Changshou factory underwent an on-site cGMP (Current Good Manufacturing Practices) inspection by the US Food and Drug Administration (referred to as "FDA") from March 25th to 29th, 2024, inspection scope of quality, production, material management, laboratory control and other relevant systems. Recently, the company received the Establishment Inspection Report (EIR) issued by the FDA for the on-site inspection, and the company passed the on-site inspection with zero deficiencies ("0-483").
This is the third time that the company's Chongqing Changshou factory has passed an on-site inspection by the FDA, following two previous inspections in 2015 and 2018. This indicates that the company's quality management system complies with the cGMP quality standards of the FDA, which is a recognition of the effective operation of the company's quality management system. It is advantageous to the company's continued provision of global pharmaceutical and biotech companies with end-to-end pharmaceutical customized R&D and production services, as well as being another milestone in the company’s mission to "become the most open, innovative, and reliable pharmaceutical service platform in the world, to make good drugs more accessible".