FDA 483 - Corium Innovations, Inc. - November 18, 2022

Corium Pharma Solutions, Inc. in Grand Rapids, MI, was inspected and cited for significant deficiencies in its manufacturing process controls, quality unit procedures, and facility sanitation. The inspection revealed inadequate process validation for Donepezil Transdermal Delivery System, failures in following written procedures for material disposition and document control, and unsanitary conditions due to lacking cleaning procedures. These issues indicate a lack of robust quality oversight and control over critical manufacturing and facility maintenance operations.