Unit Dose Solutions, Inc. – FDA 483, May 27, 2026

An FDA inspection of Unit Dose Solutions, Inc. in Raleigh, NC, a drug repacker and relabeler, revealed significant deficiencies in material control and quality unit documentation. The firm failed to establish a quarantine system for rejected components and lacked written procedures for the quality control unit's roles and responsibilities. These issues indicate a lack of adequate controls over drug product quality and compliance.