Seema International – FDA 483, May 21, 2025

An FDA inspection of Seema International, a drug product manufacturer, repackager, and relabeler in New Delhi, India, revealed severe and systemic deficiencies in their quality system, facilities, equipment, production, packaging, labeling, material, and laboratory controls. Many observations were repeats from a 2018 inspection, highlighting a persistent failure to establish and follow basic GMP requirements, including the absence of a functional quality control unit and inadequate employee training. These findings indicate a critical lack of oversight and control over drug product quality and safety.