The FDA warned API and finished drug manufacturer IDT Australia for failure to investigate quality issues and for incomplete records.
The agency found numerous CGMP violations when it inspected IDT’s facility in the Melbourne suburb of Boronia in December 2017. The investigators discovered the firm rejected a batch for assay failure in October 2015 and opened an investigation that was not closed until the following March. While the investigation found the root cause of the failure, the firm had not implemented any corrective actions as of December 2017.
The company said it would reopen the investigation and that subsequent batches met specifications, but it failed to provide any supporting data. The agency called for a detailed summary of all investigations and a plan for corrective actions.