FDA 483 - Corium Innovations, Inc. - October 27, 2017

An FDA inspection of Corium International, Inc. in Grand Rapids, MI, revealed significant deficiencies in quality control and manufacturing processes. Observations included failures to thoroughly investigate product discrepancies and patient complaints, inadequate laboratory controls for product release specifications, and a lack of validated control procedures for manufacturing processes. These issues indicate a moderate level of non-compliance with good manufacturing practices.