Office of Regulatory Affairs

E88389

federal field organization office organizational unit

The Office of Regulatory Affairs is the U.S. FDA’s primary field organization responsible for inspecting regulated products and manufacturers, enforcing compliance, and overseeing import operations to protect public health.

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All labels observed (3)

Label	Occurrences
Office of Regulatory Affairs canonical	5
FDA Office of Regulatory Affairs	1
U.S. Food and Drug Administration Office of Regulatory Affairs	1

Statements (47)

Predicate	Object
instanceOf	federal field organization ⓘ office ⓘ organizational unit ⓘ
activity	conducting import operations and examinations ⓘ conducting inspections of domestic facilities ⓘ conducting inspections of foreign facilities ⓘ initiating enforcement actions for non-compliance ⓘ
country	United States of America ⓘ
employer	FDA compliance officers ⓘ Food and Drug Administration ⓘ surface form: FDA field investigators FDA import specialists ⓘ FDA laboratory staff ⓘ
fieldOfWork	food and drug regulation ⓘ inspection and compliance ⓘ public health protection ⓘ regulatory affairs ⓘ
goal	ensure that FDA-regulated products are effective when applicable ⓘ ensure that FDA-regulated products are of high quality ⓘ ensure that FDA-regulated products are properly labeled ⓘ ensure that FDA-regulated products are safe ⓘ
hasRole	primary field organization of the U.S. FDA ⓘ
jurisdiction	United States federal law ⓘ surface form: United States federal jurisdiction
locatedIn	FDA field laboratories ⓘ United States regional and district offices ⓘ
mission	protect public health by ensuring compliance with FDA laws and regulations ⓘ
oversees	FDA district offices and resident posts ⓘ field laboratories that analyze product samples ⓘ import entry review for FDA-regulated products ⓘ
parentOrganization	Food and Drug Administration ⓘ surface form: U.S. Food and Drug Administration
partOf	Food and Drug Administration ⓘ surface form: U.S. Food and Drug Administration
regulates	biologics under FDA jurisdiction ⓘ cosmetics under FDA jurisdiction ⓘ food products under FDA jurisdiction ⓘ human drugs under FDA jurisdiction ⓘ medical devices under FDA jurisdiction ⓘ tobacco products under FDA jurisdiction ⓘ veterinary products under FDA jurisdiction ⓘ
responsibleFor	enforcement of compliance with FDA regulations ⓘ inspection of FDA-regulated manufacturers ⓘ inspection of FDA-regulated products ⓘ oversight of import operations for FDA-regulated products ⓘ protecting public health ⓘ
subjectOf	FDA organizational descriptions ⓘ U.S. federal regulatory guidance documents ⓘ
usesMethod	compliance and enforcement actions ⓘ risk-based inspection planning ⓘ sampling and laboratory analysis ⓘ

Referenced by (7)

Full triples — surface form annotated when it differs from this entity's canonical label.

Food and Drug Administration → hasDivision → Office of Regulatory Affairs ⓘ

White Oak, Maryland → isNearFederalFacility → Office of Regulatory Affairs ⓘ

this entity surface form: U.S. Food and Drug Administration Office of Regulatory Affairs

White Oak Federal Research Center → tenant → Office of Regulatory Affairs ⓘ

Office of Pharmaceutical Quality → worksWith → Office of Regulatory Affairs ⓘ

Office of Compliance → collaboratesWith → Office of Regulatory Affairs ⓘ

Office of Compliance and Biologics Quality → collaboratesWith → Office of Regulatory Affairs ⓘ

FDA field laboratories → partOf → Office of Regulatory Affairs ⓘ

this entity surface form: FDA Office of Regulatory Affairs