SPR Therapeutics drew a Form 483 for inadequate complaint handling procedures.
The FDA inspected the firm’s Cleveland, Ohio facility in February 2018. The firm claimed that it had contacted a supplier regarding a complaint and determined the cause was likely a manufacturing issue, but could provide no communication or investigation documentation.
It also did not properly establish its supplier qualification and monitoring procedures. It was unclear how its pre-audit questionnaires for suppliers were used and analyzed.