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U.S. Department of Health and Human Services

For Industry

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  • Dispute Resolution

    Dispute Resolution

    The Office of the Ombudsman is a resource for individuals and for companies when they are experiencing problems with the regulatory process or with the application of FDA policies or procedures. The Office of the Ombudsman provides assistance if there are problems or concerns that are not being addressed, or cannot be addressed, at the center or district level, or when there are concerns about raising an issue at that level. If requested, confidentiality will be maintained by the Office of the Ombudsman to the greatest extent possible.


    Contact FDA

    (301) 796-8530
    Fax:(301) 847-8628
    FDA Office of the Ombudsman

    Laurie Lenkel, Director

    Andrew Moss, Deputy Ombudsman

    10903 New Hampshire Avenue

    WO 32, Room 4231

    Silver Spring, MD 20993