Office of Compliance
E392788
The Office of Compliance is a regulatory body within the U.S. Food and Drug Administration’s drug oversight framework that enforces laws and standards to ensure the safety, quality, and proper marketing of pharmaceutical products.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Office of Compliance canonical | 2 |
How this entity was disambiguated
This entity first appeared as the object of triple T3849414 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Office of Compliance Context triple: [Center for Drug Evaluation and Research, oversees, Office of Compliance]
-
A.
Office of Compliance
The Office of Compliance is a division within the U.S. Environmental Protection Agency’s Office of Enforcement and Compliance Assurance that oversees and promotes adherence to federal environmental laws and regulations.
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B.
Office of Quality and Compliance
The Office of Quality and Compliance is a division within the Oregon Department of Human Services responsible for overseeing adherence to standards, regulations, and best practices to ensure effective and accountable delivery of human services.
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C.
Office of Enforcement and Compliance Assurance
The Office of Enforcement and Compliance Assurance is the U.S. EPA division responsible for enforcing federal environmental laws and ensuring regulated entities comply with environmental standards.
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D.
Office of Enforcement
The Office of Enforcement is a division within the U.S. Bureau of Safety and Environmental Enforcement responsible for ensuring compliance with offshore energy safety and environmental regulations through inspections, investigations, and enforcement actions.
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E.
Office of Integrity and Oversight
The Office of Integrity and Oversight is a governmental unit responsible for promoting accountability, ethical conduct, and effective oversight within the District of Columbia’s financial operations.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Office of Compliance Target entity description: The Office of Compliance is a regulatory body within the U.S. Food and Drug Administration’s drug oversight framework that enforces laws and standards to ensure the safety, quality, and proper marketing of pharmaceutical products.
-
A.
Office of Compliance
The Office of Compliance is a division within the U.S. Environmental Protection Agency’s Office of Enforcement and Compliance Assurance that oversees and promotes adherence to federal environmental laws and regulations.
-
B.
Office of Quality and Compliance
The Office of Quality and Compliance is a division within the Oregon Department of Human Services responsible for overseeing adherence to standards, regulations, and best practices to ensure effective and accountable delivery of human services.
-
C.
Office of Enforcement and Compliance Assurance
The Office of Enforcement and Compliance Assurance is the U.S. EPA division responsible for enforcing federal environmental laws and ensuring regulated entities comply with environmental standards.
-
D.
Office of Enforcement
The Office of Enforcement is a division within the U.S. Bureau of Safety and Environmental Enforcement responsible for ensuring compliance with offshore energy safety and environmental regulations through inspections, investigations, and enforcement actions.
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E.
Office of Integrity and Oversight
The Office of Integrity and Oversight is a governmental unit responsible for promoting accountability, ethical conduct, and effective oversight within the District of Columbia’s financial operations.
- F. None of above. chosen
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
FDA office
ⓘ
regulatory body ⓘ |
| appliesTo |
biological drug products
ⓘ
drug distribution ⓘ drug labeling ⓘ drug manufacturing facilities ⓘ drug promotion and advertising ⓘ generic drugs ⓘ human prescription drugs ⓘ over-the-counter drugs ⓘ |
| collaboratesWith |
Department of Justice
ⓘ
linked to:
United States Department of Justice
Office of Regulatory Affairs ⓘ other FDA centers ⓘ state regulatory authorities ⓘ |
| country |
United States
ⓘ
linked to:
United States of America
|
| goal |
ensure that marketed drugs are safe and effective as labeled
ⓘ
prevent distribution of adulterated and misbranded drugs ⓘ protect public health by ensuring that drugs meet applicable standards ⓘ |
| jurisdiction |
United States
ⓘ
linked to:
United States of America
|
| legalBasis |
FDA regulations in Title 21 of the Code of Federal Regulations
ⓘ
Federal Food, Drug, and Cosmetic Act ⓘ Public Health Service Act ⓘ |
| locatedIn | Silver Spring, Maryland ⓘ |
| parentAgency |
U.S. Food and Drug Administration
ⓘ
linked to:
Food and Drug Administration
|
| parentOrganization | Center for Drug Evaluation and Research ⓘ |
| partOf |
Center for Drug Evaluation and Research
ⓘ
U.S. Food and Drug Administration ⓘ
linked to:
Food and Drug Administration
|
| responsibleFor |
coordinating drug recall activities
ⓘ
enforcing drug-related provisions of the Federal Food, Drug, and Cosmetic Act ⓘ ensuring compliance with advertising and promotion requirements for drugs ⓘ ensuring compliance with current good manufacturing practice requirements ⓘ ensuring compliance with labeling requirements for drugs ⓘ ensuring drug quality ⓘ ensuring drug safety ⓘ ensuring proper marketing of pharmaceutical products ⓘ evaluating compliance of drug firms with FDA regulations ⓘ guidance development for industry on compliance issues ⓘ initiating enforcement actions for drug violations ⓘ issuing warning letters to drug manufacturers ⓘ oversight of adulterated drug products ⓘ oversight of data integrity issues in drug applications and manufacturing records ⓘ oversight of drug manufacturing inspections ⓘ oversight of unapproved and misbranded drug products ⓘ policy development related to drug compliance and enforcement ⓘ recommending civil monetary penalties ⓘ recommending injunctions ⓘ recommending product seizures ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Office of Compliance Description of subject: The Office of Compliance is a regulatory body within the U.S. Food and Drug Administration’s drug oversight framework that enforces laws and standards to ensure the safety, quality, and proper marketing of pharmaceutical products.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.