FDA-TRACK: Office of Inspections and Investigations Dashboard
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The Office of Inspections and Investigations (OII) is the lead office for all FDA field inspection, investigation, imports, and emergency response activities. OII will continue to inspect, investigate, screen imports, and respond to emergency activities to ensure that food, feed, and medical products are safe and effective for the American public.
The Office of Inspections and Investigations (OII) is the lead office for all FDA field inspection, investigation, imports, and emergency response activities. OII will continue to inspect, investigate, screen imports, and respond to emergency activities to ensure that food, feed, and medical products are safe and effective for the American public.
FDA’s reorganization transferred compliance and enforcement responsibilities to the Human Food Program (HFP), FDA Centers, and Office of Chief Scientist (OCS), including the final inspection and reinspection timeline decisions for non-compliance firms. OII will reinspect FDA regulated firms for corrective actions following compliance reinspection requests.
Compliance Inspection Measures
For FY25, as FDA continues implementing the reorganization, OII will report the compliance inspection performance measures, in collaboration with HFP, FDA Center, and OCS decisions. The FY25 FDA-TRACK compliance inspection performance measures will be provided annually.
Proportion of significant inspection violations which receive appropriate follow-up after regulatory action was taken
This performance measure was developed to track and promote an increase to the percentage of firms with significant violations that receive appropriate follow-up, whether follow-up is through a physical FDA visit to a firm or through correspondence with the firm. All firms included in this performance measure had significant inspection violations that led to formal regulatory actions by FDA. Confirmation that a firm has made appropriate corrections following FDA regulatory actions is important to ensure the risk to public health is minimized.
- Follow-up: Any physical visit or other documented confirmation of communication to the firm.
- No Follow-up: No physical visit or documented confirmation of communication to the firm.
- Significant Violation: Violations that may lead to enforcement action if not promptly and adequately corrected. This performance goal focuses on significant inspection violations that are classified as Official Action Indicated.
Proportion of follow-up inspections conducted due to regulatory action on significant inspection violations that moved toward compliance
This performance goal was developed to track and promote an increase to the percentage of firms that move toward compliance after a significant inspection violation. This dataset includes firms that had physical follow-up visits after regulatory action was taken by FDA on significant inspection violations. To reduce the risk to public health, FDA strives to have all firms meet compliance standards.
- In Compliance: No administrative or regulatory actions are recommended. This includes classifications of NAI and VAI.
- Out of Compliance: Administrative or regulatory actions are recommended. This includes the OAI classification.
- Significant Violation: Violations that may lead to enforcement action if not promptly and adequately corrected. This performance goal focuses on significant inspection violations that are classified as Official Action Indicated.
Download FDA-TRACK OII Dataset
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.