FDA 483 - SPR Therapeutics Inc. - February 22, 2018

An FDA inspection of SPR Therapeutics Inc., a medical device manufacturer in Cleveland, OH, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling customer complaints, including documentation of investigations and supplier corrective actions. Additionally, procedures for qualifying and monitoring suppliers were found to be insufficient, lacking clear guidelines for evaluating pre-audit questionnaires and defining triggers for further action.