Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Office of the Chief Scientist

Office of the Chief Scientist
            
                        Office of Counterterrorism and Emerging Threats
          Office of Regulatory Science and Innovation
          Office of Scientific Integrity
          Office of Scientific Professional Development


                        Office of Laboratory Safety
          National Center for Toxicological Research
          Guidance Documents by the Office of the Chief Scientist Home
          About FDA
          FDA Organization
          Office of the Commissioner
          Office of the Chief Scientist
          Office of the OmbudsmanOffice of the Chief Scientist Office of the Ombudsman

    
Share
    Post
    Linkedin

    Email
    PrintImage
              FDA's Office of the Ombudsman; Consultation; Dispute Resolution; MediationBrochure: Office of the Ombudsman

The FDA Office of the Ombudsman is the Agency's focal point for addressing complaints and assisting in resolving disputes between companies or individuals and FDA offices concerning fair and even-handed application of FDA policy and procedures.

It serves as a neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process that have not been resolved at the center or district level.

The Office works to resolve externally generated problems for which there are no legal or established means of redress by finding approaches that are acceptable to the affected party and the Agency.

**Type of Cases Handled**

Disputes from regulated industry regarding agency product center or District Office actions.
	Disputes about import detentions.
	Complaints from small businesses, including those referred by the U.S. Small Business Administration.
	Inquiries about the agency's handling of consumer complaints.
	Requests for information and assistance from regulated industry.**Additional Functions**

Coordination of Appeals from decisions made by offices within the Office of the Commissioner under 21 CFR 10.75.
	Coordination of certain administrative hearings that fall under 21 CFR Part 16.**Staff**

Laurie Lenkel, Director
Talisha Williams, Assistant Ombudsman
Phone: (301) 796-8530
Fax: (301) 595-8041

E-mail: ombuds@oc.fda.gov

Resources for You

Brochure: FDA's Office of the Ombudsman
	Non-Retaliation Policy
	Product Center Ombudsmen
	SBA National Ombudsman

                                                                                  Content current as of:
      09/23/2021Office of the Chief Scientist
            
          
                        Office of Counterterrorism and Emerging Threats
          Office of Regulatory Science and Innovation
          Office of Scientific Integrity
          Office of Scientific Professional Development


                        Office of Laboratory Safety
          National Center for Toxicological Research
          Guidance Documents by the Office of the Chief Scientist
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop