FDA 483 - Aurohealth LLC - April 11, 2019

An FDA inspection of Aurohealth LLC in Lawrence Township, NJ, revealed significant deficiencies in equipment calibration and cleaning validation. The firm failed to ensure scales were appropriately calibrated for weighing raw materials and lacked adequate cleaning procedures and validation for manufacturing equipment, including transfer hoses. These issues raise concerns about the accuracy of drug product formulation and the prevention of cross-contamination.