FDA 483 - 8046255 Canada Inc. DBA Viatrexx - September 24, 2019

The FDA inspected 8046255 Canada Inc. DBA Viatrexx, a sterile injectable drug product manufacturer in Beloeil, from September 16-24, 2019. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, laboratory controls, and quality control record-keeping, indicating a severe lack of adherence to cGMP for sterile drug manufacturing. These issues raise serious concerns about the sterility and quality assurance of their injectable drug products.