FDA 483 - Corium Innovations, Inc. - September 16, 2019

An FDA inspection of Corium International, Inc. in Grand Rapids, MI, revealed significant deficiencies in the firm's procedures for handling written and oral complaints related to drug products. Issues included miscategorization of complaints, inadequate root cause analysis, failure to test retain samples when justified, and a lack of procedures for investigating complaints involving adverse events. These findings indicate a need for improved quality control and complaint management systems.