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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Office of Inspections and Investigations Dashboard

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.

  1. Follow-up: Any physical visit or other documented confirmation of communication to the firm.
  2. No Follow-up: No physical visit or documented confirmation of communication to the firm.
  3. 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.

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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.

  1. In Compliance: No administrative or regulatory actions are recommended. This includes classifications of NAI and VAI.
  2. Out of Compliance: Administrative or regulatory actions are recommended. This includes the OAI classification.
  3. 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.

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Laboratory Measures

FDA’s reorganization transferred ORA’s laboratory operations to the Office of Chief Scientist and the Human Foods Program. OII will not be reporting the FY25 laboratory accreditation or surge capacity performance measures.

Maintain accreditation for ORA labs

FDA is a science-based agency that depends on its regulatory laboratories for timely, accurate, and defensible analytical results in meeting its consumer protection mandate. Our laboratories have enjoyed a long history of excellence in science upon which the agency has built its reputation as a leading regulatory authority in the world health community. Accreditation of laboratory quality management systems provides a mechanism for harmonizing and strengthening processes and procedures, thereby improving the quality of operations and the reliability of FDA's science. Such accreditations allow FDA to maintain its reputation as a source of scientifically sound information and guidance both domestically and in the international arena.

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Increase laboratory surge capacity in the event of terrorist attack on the food supply (radiological and chemical samples/week)

A critical component of controlling threats from deliberate food-borne contamination is the ability to rapidly test large numbers of samples of potentially contaminated foods for the presence of contaminants. To address the need for this surge capacity, The Food Emergency Response Network (FERN), a joint effort between USDA/FSIS and HHS/FDA, was created. FERN is a nationwide laboratory network that integrates existing federal and State food testing laboratory resources capable of analyzing foods for agents of concern in order to prevent, prepare for, and respond to national emergencies involving unsafe food products. Improvements in surge capacity will have public health value even in non-deliberate food contamination by assisting FDA in identifying and removing contaminated food products from the marketplace as soon as possible in order to protect the public health and mitigate disruption in the U.S. food supply chain.

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Download ORA Dataset

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons.

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