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 of it.
It also did not properly establish its supplier qualification and monitoring procedure. It was unclear how its pre-audit questionnaires for suppliers are used and analyzed.
One pre-audit questionnaire answered by a supplier included negative responses on specific quality questions, but the firm did not document its acceptance of the responses or put in place appropriate monitoring activities for the supplier.