FDA 483 - Veranova LP - February 15, 2023

An FDA inspection of Veranova, L.P. in West Deptford, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately investigate customer complaints regarding inaccurate API documentation and implement effective corrective actions. Additionally, the inspection found that the company lacked sufficient written procedures for cleaning validation of non-dedicated manufacturing equipment, with a related CAPA remaining open for an extended period.