FDA EIR - Fujian South Pharmaceutical Co. Ltd - October 11, 2024

An FDA pre-surveillance inspection of Fujian South Pharmaceutical Co. Ltd, located in Mingxi County, China, was conducted from October 7-11, 2024. This inspection, carried out under eNSpect PAC codes 46832 and 56002F and guided by ICH Q7 and Good Manufacturing Practices (GMPs), focused on the company’s Active Pharmaceutical Ingredient (API) manufacturing operations. The inspection aimed to evaluate readiness for commercial manufacturing, conformance to submissions, data integrity, and commitment to quality. A significant finding was that the inspection concluded with no issuance of an FDA Form 483, indicating no new regulatory violations were observed. The report highlighted that all five observations from a previous FDA inspection in September 2015, which concerned laboratory stability testing, method verification, equipment calibration, and equipment qualification, were thoroughly verified as corrected during this visit. Fujian South Pharmaceutical Co. Ltd demonstrated established quality, production, facilities and equipment, laboratory control, materials, and packaging and labeling systems. The review of original records, manufacturing processes, and quality controls revealed accuracy, completeness, and adherence to regulatory expectations. Management's active role in ensuring product quality and fostering a culture of integrity was also noted. This positive outcome reflects the company's commitment to maintaining high pharmaceutical manufacturing standards without requiring any new immediate actions from the FDA.