FDA 483 - IDO PHARM - November 10, 2025

IDO Pharm, an OTC drug manufacturer in Ansan-si, Gyeonggi-do, Republic of Korea, was cited for significant deficiencies across its quality systems. The inspection revealed widespread issues including unvalidated laboratory methods, inadequate equipment cleaning and maintenance, lack of process and environmental monitoring, and incomplete batch records. These conditions indicate a severe lack of control over critical manufacturing and testing processes, posing risks to drug product quality and patient safety.