Office of Global Regulatory Operations and Policy

It is organized into five regions - Northeast (NER), Central (CER), Southeast (SER), Southwest (SWR) and Pacific (PAR).{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm135269.htm |archive-url=https://web.archive.org/web/20111124170424/http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm135269.htm |url-status=dead |archive-date=November 24, 2011 |title= U.S. FDA ORA Offices & Divisions |website=U.S. FDA Organization |publisher=U.S. Food & Drug Administration}} Each region is structured into district and resident post offices. There are a total of 20 district offices, nineteen of which handle both imported and domestic products and one import only district (Southwest Import, referred to as "SWID").{{cite web |url=https://www.fda.gov/ForIndustry/ImportProgram/ |archive-url=https://web.archive.org/web/20121124135203/http://www.fda.gov/ForIndustry/ImportProgram/ |url-status=dead |archive-date=November 24, 2012 |title= U.S. FDA Import Program |website=U.S. FDA for Industry |date= 23 February 2023 |publisher=U.S. Food & Drug Administration}} Districts, with the exception of the Southwest Imports District (SWID), are referred to by a three letter name followed by "DO", such as MIN-DO for Minneapolis District.

Each district office consists of three branches reporting to a district director. The majority of the staff are part of an Investigations Branch that performs routine inspections of manufacturers and imported products, issuance of the FDA 483, complaint investigations, audits of recalls, collections of samples, and other related tasks.{{cite web |url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations |title= U.S. FDA Inspection Observations |website=U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 21 November 2022 |publisher=U.S. Food & Drug Administration}} These staff are mostly Consumer Safety Officers (CSOs, "Investigators") or Consumer Safety Inspectors (CSIs, "Inspectors"). ORA no longer routinely hire CSIs, most new staff are CSOs. These staff have a variety of administrative authorities and enforce the civil law requirements of the Food, Drug, and Cosmetic Act as well as parts of the Public Health Service Act.{{cite web |url=https://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm |archive-url=https://web.archive.org/web/20090710011326/http://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm |url-status=dead |archive-date=July 10, 2009 |title= Public Health Service Act |website=U.S. FDA Legislation |publisher=U.S. Food & Drug Administration}} Some are also commissioned officers of the Public Health Service,{{cite web |url= http://www.usphs.gov/ |title= U.S. Public Health Service Commissioned Corps |website= USPHS America's Health Responders |publisher= U.S. Public Health Service |access-date= 2011-09-21 |archive-url= https://web.archive.org/web/20090506174822/http://www.usphs.gov/ |archive-date= 2009-05-06 |url-status= dead }} but this does not generally affect day-to-day duties. These staff are generally technical or scientific and are not involved in criminal law enforcement which is handled by a separate branch of FDA called OCI, though many criminal investigations are started by ORA referring a case to OCI.

The district offices also include a Compliance Branch. Compliance Officers handle the administrative authorities used in inspections, such as issuing Warning Letters.{{cite web |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ |archive-url=https://web.archive.org/web/20100828124923/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ |url-status=dead |archive-date=August 28, 2010 |title= U.S. FDA Warning Letters |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 2 November 2022 |publisher=U.S. Food & Drug Administration}} They also organize civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.

The final branch is an Administrative Branch which handles budgeting, some aspects of payroll, and other administrative tasks. Regional and national regulatory experts are often located at district offices, but are not administratively part of those offices.

The districts also include resident posts, typically in major cities or at major border crossings. These are generally only Investigations Branch staff.

The Office of Regulatory Affairs operates thirteen field laboratories. The field science laboratories were historically part of the FDA districts infrastructure but are now independent entities. ORA has five regional, six district, and two specialty laboratories such as the Forensic Chemistry Center (FCC) and the Winchester Engineering and Analytical Center (WEAC).{{cite web |url=https://www.fda.gov/science-research/field-science-and-laboratories |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |date= 27 February 2023 |publisher=U.S. Food & Drug Administration}}

ORA operations are generally conducted according to the Compliance Program Guidance Manual (CPGM),{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |archive-url=https://web.archive.org/web/20111212175858/http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |url-status=dead |archive-date=December 12, 2011 |title= U.S. FDA Compliance Program Guidance Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 2 August 2021 |publisher=U.S. Food & Drug Administration}} Investigations Operations Manual (IOM),{{cite web |url=https://www.fda.gov/ICECI/Inspections/IOM/ |archive-url=https://web.archive.org/web/20121018165229/http://www.fda.gov/ICECI/Inspections/IOM/ |url-status=dead |archive-date=October 18, 2012 |title= U.S. FDA Investigations Operations Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |date= 17 January 2023 |publisher=U.S. Food & Drug Administration}} and the Regulatory Procedures Manual (RPM).{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |archive-url=https://web.archive.org/web/20120403153338/http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |url-status=dead |archive-date=April 3, 2012 |title= U.S. FDA Regulatory Procedures Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}

{{reflist}}

{{Portal|Food|United States|Politics|Law|Medicine}}

• [https://web.archive.org/web/20160311071946/http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ U.S. FDA Forms]
• [https://www.fda.gov/RegulatoryInformation/Guidances/ U.S. FDA Guidances]{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}
• [https://web.archive.org/web/20150213024540/http://www.fda.gov/ICECI/Inspections/InspectionGuides/ U.S. FDA Inspection Guides]
• [https://web.archive.org/web/20150213024409/http://www.fda.gov/ICECI/Inspections/ForeignInspections/ U.S. FDA International Inspections & Travel]
• [https://www.fda.gov/science-research/field-science-and-laboratories/field-science-laboratory-manual U.S. FDA Laboratory Manual]
• [https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ U.S. FDA Medical Device Quality Systems Manual]{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}}
• [https://web.archive.org/web/20090709215930/http://www.fda.gov/downloads/ICECI/Inspections/UCM142981.pdf U.S. FDA Medical Device Quality Systems Regulation/Design Controls]

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