FDA 483 - Innocore Sales & Marketing Inc. - April 25, 2025

Innocore Sales & Marketing Inc., a human drug manufacturer in Woodstock, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight critical failures in process validation, component identity testing, test method validation, equipment maintenance, and quality control record-keeping, with several issues being repeat observations from a prior inspection. These findings indicate a lack of adequate controls to ensure the quality, safety, and purity of their drug products.