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                FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Agency-wide Program Performance

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Relevant Links:

1. Office of Regulatory Affairs
	2. FDA Efforts to Ensure Product Safety


FDA's Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.  ORA also develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans.


FDA's Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA's performance measures focus on import screening activities, laboratory capacity, and domestic and foreign inspections to ensure that food, feed and medical products available to the American public are safe and effective. Explore the progress ORA is making to protect public health below.


Proportion of significant inspection violations which receive appropriate follow-up after regulatory action was taken





**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.

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Proportion of follow-up inspections conducted due to regulatory action on significant inspection violations that moved toward compliance





**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.

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Maintain accreditation for ORA labs



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



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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.*

                                                                                  Content current as of:
      11/13/2023FDA-TRACK: Agency-wide Program Performance

          
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