FDA 483 - Paxeuticals LLC - April 20, 2026

During an inspection from April 14-20, 2026, Paxuticals LLC, a contract packager in Parsippany, NJ, received six observations related to significant deficiencies in their manufacturing and quality control processes. The firm failed to establish adequate production and process controls, properly qualify equipment, maintain a functional quality control unit, ensure equipment cleanliness, maintain complete batch records, and store drug products under appropriate conditions.