FDA 483 - S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED - July 21, 2023

An FDA inspection of S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED in Si Racha, Thailand, a manufacturer, revealed significant deficiencies in laboratory control systems and quality control unit responsibilities. Observations included failures to maintain complete records for laboratory reference standards and test calculations, as well as a lack of proper written procedures and authority for the quality control unit, leading to concerns about data integrity and batch record control.