FDA began inspections for Intentional Adulteration (IA) Rule components in March 2020, including assessment of Food Defense mitigation strategies, verification of effectiveness and the development of corrective action steps to be taken in the event that the mitigation strategy was not implemented properly or did not effectively protect against adulteration. Thorough documentation of mitigation plans, verification assessments as well as planned corrective actions are a key part of ensuring compliance with the IA Rule.
EAS Consulting Group helps firms prepare for FDA inspections with our mock-inspection program where EAS consultants, former FDA inspection officials, complete a simulated inspection covering documentation, verification appropriateness of Food Defense processes and recommendations for corrective actions.
EAS’s mock-inspection and mock-audit programs provide an early view of your firm’s readiness and an opportunity to make improvements prior to FDA knocking on your door.
Posted in Did You Know, Foods.