FDA 483 - Apotex Pharmachem Inc. - December 16, 2022

An FDA inspection of Apotex Pharmachem Inc. in Brantford, Canada, an API manufacturer, identified two significant observations. The firm's validation of a stability-indicating method for an active pharmaceutical ingredient was deemed inadequate, with issues in forced degradation studies. Additionally, the inspection revealed a failure to sign off and lock completed projects in their EMPOWER 3 computerized system, which is contrary to their established standard operating procedures.