Vantage Specialty Ingredients, Inc. – FDA 483, Jan 23, 2026

Vantage Specialty Ingredients, Inc. in Fairfield, NJ, a repacker/relabeler, was cited for significant deficiencies in its quality unit, laboratory controls, and data integrity during an FDA inspection. Observations included failures in annual product reviews, change control, sample examination, vendor qualification, computerized system controls, analytical method validation, equipment qualification, stability testing, employee training, and customer complaint investigations. These issues indicate a broad lack of adherence to current good manufacturing practices for Bulk Active Pharmaceutical Ingredients.