FDA 483 - Innocore Sales & Marketing Inc. - June 06, 2019

An FDA inspection of Innocore Sales & Marketing Inc., a drug manufacturer in Woodstock, revealed significant deficiencies across its quality, production, laboratory, and equipment systems. The firm lacked numerous essential written procedures, including those for change controls, nonconformance, CAPA, reprocessing, process validation, annual product review, and stability testing. Additionally, the inspection found issues with master production records, component testing, labeling control, product release testing, and equipment documentation, indicating a broad failure to adhere to cGMP requirements for drug products distributed to the United States.