IDO PHARM – FDA Warning Letter, Nov 13, 2025

The FDA issued a warning letter to South Korean drug manufacturer IDO Pharm Co., Ltd. following an inspection of its facility conducted from November 10 to 13, 2025. The inspection revealed critical violations of Current Good Manufacturing Practice (CGMP) standards, as outlined in the Federal Food, Drug, and Cosmetic Act. These failures led the FDA to classify the company’s drug products as adulterated and place the firm on a nationwide import alert.

Primary violations included a significant lack of control over the manufacturing water system, where inspectors observed stagnant water and physical contaminants, including an insect, in storage tanks. Additionally, the company failed to validate its manufacturing processes and equipment cleaning procedures for over-the-counter drugs. Laboratory oversight was also found to be deficient; the firm used unvalidated testing methods and failed to properly screen raw materials for impurities. The company’s Quality Unit further failed to ensure accurate production records, regular equipment calibration, and adequate stability testing to support product expiration dates.

To address these issues, the FDA requires IDO Pharm Co., Ltd. to perform comprehensive risk assessments for all products currently distributed in the U.S. market. The firm must provide detailed remediation plans for its water system, manufacturing processes, and laboratory practices. Furthermore, the FDA strongly recommends that the company hire an independent consultant to conduct a full audit and assist in bringing the facility into compliance with international safety and quality standards.