USApedia

Office of Global Regulatory Operations and Policy: Difference between revisions

Page Discussion

Office of Global Regulatory Operations and Policy (view source)

Revision as of 11:55, 9 January 2025

144 bytes added ,  9 January
→‎Organization
VisualWikitext
Line 33: Line 33:
== Organization ==
== Organization ==


It is organized into five regions - Northeast (NER), Central (CER), Southeast (SER), Southwest (SWR), and Pacific (PAR). <ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm135269.htm |title= U.S. FDA ORA Offices & Divisions |website=U.S. FDA Organization |publisher=U.S. Food & Drug Administration}}</ref> 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").<ref>{{cite web |url=https://www.fda.gov/ForIndustry/ImportProgram/ |title= U.S. FDA Import Program |website=U.S. FDA for Industry |publisher=U.S. Food & Drug Administration}}</ref> 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.
=== Regions ===
It is organized into five regions -  


Each district office consists of three branches reporting to a district director:
* Northeast (NER)
* '''Investigations Branch''': The majority of the staff are part of this branch, which performs routine inspections of manufacturers and imported products, issuance of the [[Form FDA 483|FDA 483]], complaint investigations, audits of recalls, collections of samples, and other related tasks.<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/ucm250720.htm |title= U.S. FDA Inspection Observations |website=U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> These staff are mostly Consumer Safety Officers (CSOs, "Investigators") or Consumer Safety Inspectors (CSIs, "Inspectors"). ORA no longer routinely hires CSIs; most new staff are CSOs. These staff have a variety of administrative authorities and enforce the civil law requirements of the [[Federal Food, Drug, and Cosmetic Act|Food, Drug, and Cosmetic Act]] as well as parts of the [[Public Health Service Act]].<ref>{{cite web |url=https://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm |title= Public Health Service Act |website=U.S. FDA Legislation |publisher=U.S. Food & Drug Administration}}</ref> Some are also commissioned officers of the [[Public Health Service]],<ref>{{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 }}</ref> 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 [[Office of Criminal Investigations|OCI]], though many criminal investigations are started by ORA referring a case to OCI.
* Central (CER),  
* Southeast (SER),  
* Southwest (SWR), and  


* '''Compliance Branch''': Compliance Officers handle the administrative authorities used in inspections, such as issuing [[FDA Warning Letter|Warning Letters]].<ref>{{cite web |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ |title= U.S. FDA Warning Letters |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> They also organize civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.
Pacific (PAR). <ref>{{cite web |url=https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ucm135269.htm |title= U.S. FDA ORA Offices & Divisions |website=U.S. FDA Organization |publisher=U.S. Food & Drug Administration}}</ref> 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").<ref>{{cite web |url=https://www.fda.gov/ForIndustry/ImportProgram/ |title= U.S. FDA Import Program |website=U.S. FDA for Industry |publisher=U.S. Food & Drug Administration}}</ref> 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.


* '''Administrative Branch''': This branch 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.
=== District offices ===
Each district office consists of three branches reporting to a district director, listed below.
The districts also include resident posts, typically in major cities or at major border crossings. These are generally only Investigations Branch staff.
 
==== '''Investigations Branch''' ====
The majority of the staff are part of this branch, which performs routine inspections of manufacturers and imported products, issuance of the [[Form FDA 483|FDA 483]], complaint investigations, audits of recalls, collections of samples, and other related tasks.<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/ucm250720.htm |title= U.S. FDA Inspection Observations |website=U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> These staff are mostly Consumer Safety Officers (CSOs, "Investigators") or Consumer Safety Inspectors (CSIs, "Inspectors"). ORA no longer routinely hires CSIs; most new staff are CSOs. These staff have a variety of administrative authorities and enforce the civil law requirements of the [[Federal Food, Drug, and Cosmetic Act|Food, Drug, and Cosmetic Act]] as well as parts of the [[Public Health Service Act]].<ref>{{cite web |url=https://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm |title= Public Health Service Act |website=U.S. FDA Legislation |publisher=U.S. Food & Drug Administration}}</ref> Some are also commissioned officers of the [[Public Health Service]],<ref>{{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 }}</ref> 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 [[Office of Criminal Investigations|OCI]], though many criminal investigations are started by ORA referring a case to OCI.
 
==== '''Compliance Branch''': ====
Compliance Officers handle the administrative authorities used in inspections, such as issuing [[FDA Warning Letter|Warning Letters]].<ref>{{cite web |url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ |title= U.S. FDA Warning Letters |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> They also organize civil litigation (such as a seizure or injunction) which is brought to the courts by the United States District Attorneys.


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


=== Field laboratories ===
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).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |publisher=U.S. Food & Drug Administration}}</ref>
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).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |publisher=U.S. Food & Drug Administration}}</ref>


== Manuals ==
ORA operations are generally conducted according to the:
ORA operations are generally conducted according to the:
* '''Compliance Program Guidance Manual (CPGM)''',<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |title= U.S. FDA Compliance Program Guidance Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>
* '''Compliance Program Guidance Manual (CPGM)''',<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |title= U.S. FDA Compliance Program Guidance Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>
Line 51: Line 65:
* '''Regulatory Procedures Manual (RPM)'''.<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |title= U.S. FDA Regulatory Procedures Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>
* '''Regulatory Procedures Manual (RPM)'''.<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |title= U.S. FDA Regulatory Procedures Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref>


==Related==
==References==
==References==
{{reflist}}
{{reflist}}
Retrieved from ‘https://openusaproject.com/wiki/Special:MobileDiff/20733’