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                Office of Regulatory Affairs

Office of Regulatory Affairs
              
                        FDA/ORA Efforts to Ensure Product Safety
          ORA Recruitment Handouts
          Jobs at the Office of Regulatory Affairs (ORA)
          Office of Regulatory Affairs Senior Executive Team


                        ORA Program Areas
          Regulatory News, Stories, and Features
          Contact ORA
          ORA FOIA Electronic Reading Room Home
          About FDA
          FDA Organization
          Office of Regulatory AffairsFDA Organization Office of Regulatory Affairs
    Also referred to as: ORA

    
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    PrintThe U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts.

Vision

Public health is protected, promoted, and advanced


Mission

Protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products

What We Do
	**Recalls & Alerts**

			Recalls, Market Withdrawals, & Safety Alerts
				Import Alerts
				Enforcement Reports**Program Areas**

			Import Program (Office of Import Operations)
				Bioresearch Monitoring (Office of Bioresearch Monitoring Operations)
				Human and Animal Food (Office of Human and Animal Food Operations)
				Medical Device & Radiological Health (Office of Medical Device and Radiological Health Operations)**Other Topics**

			Criminal Investigations
				Federal, State, Local, Tribal, and Territorial Officials
				Field Sciences and Laboratories
				Health Fraud Scams
				Inspections & Compliance
				Training, Education, and Development for ORA Employees/Partners
				ORA FOIA Electronic Reading Room

ORA Core Values
	ORA Core Values

			Accountability -We take personal responsibility for meeting individual, team, and organizational commitments.
				Commitment to Public Health -We demonstrate our commitment to safeguarding the public health in our actions.
				Communication -We provide information that is accurate and clear, and in our interactions with others, we actively listen to understand other points of view.
				Inclusion, Diversity, Equity, and Accessibility -We embrace each individual’s uniqueness and seek out their ideas and perspectives.
				Integrity and Respect -We adhere to the highest ethical standards by consistently being honest and trustworthy in our actions.
				**Quality**- We set high standards of excellence for our work and take the necessary actions to continuously improve.

View ORA Compliance and Inspection Manuals
	Compliance Manuals/Guides

			Compliance Policy Guides (CPG)
				Compliance Program Guidance Manual(CP)
				Regulatory Procedures Manual (RPM)
			Inspection Manuals/Guides

			Investigations Operations Manual (IOM)
				Inspection Guides
				Inspection Technical Guides

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                                                                                  Content current as of:
      05/11/2023Office of Regulatory Affairs
              
          
                        FDA/ORA Efforts to Ensure Product Safety
          ORA Recruitment Handouts
          Work at ORA
          Office of Regulatory Affairs Senior Executive Team


                        ORA Program Areas
          Regulatory News, Stories, and Features
          Contact ORA
          ORA FOIA Electronic Reading Room
 
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