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

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 United States Department of Justice
surface form: Department of Justice

Office of Regulatory Affairs
other FDA centers
state regulatory authorities
country United States of America
surface form: United States
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 of America
surface form: United States
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 Food and Drug Administration
surface form: U.S. Food and Drug Administration
parentOrganization Center for Drug Evaluation and Research
partOf Center for Drug Evaluation and Research
Food and Drug Administration
surface form: U.S. 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

Referenced by (2)

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

Office of Pharmaceutical Quality worksWith Office of Compliance