The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

SPR Therapeutics Blasted for Customer Complaint Handling

May 4, 2018

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.

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