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Medical Devices / Inspections and Audits

SPR Therapeutics Cited for Complaint Handling

May 9, 2018
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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.

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