FDA 483 - International Nutrition Inc - July 25, 2025

International Nutrition Inc, a manufacturer in Omaha, NE, was cited for significant deficiencies in its quality control processes for drug components used in Type A medicated articles. The firm failed to adequately test incoming raw materials, including not adhering to current USP monographs, lacking identity testing, and not testing for specific compounds. These issues were observed without sufficient scientific justification, indicating a serious lapse in ensuring the integrity and identification of drug components.