FDA 483 - International Nutrition Inc - July 25, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 269d2711-e5b6-4f26-97f4-024bb8847886