FDA 483 - Niagara Pharmaceuticals Inc - April 25, 2022

Niagara Pharmaceuticals Inc, a manufacturer in Dundas, was inspected by the FDA, resulting in four observations. The inspection revealed deficiencies in quality control unit procedures, vendor qualification, sampling criteria for packaging materials, manufacturing process validation, and the determination of actual and theoretical yields. These issues indicate a need for improved adherence to Good Manufacturing Practices.