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ORA Ombudsman

Core Standards of the Ombudsman: Independence, Informality, Impartiality, and Confidentiality (when warranted).


ORA Ombudsman Vision & Mission

Vision: To enhance the FDA Office of Regulatory Affairs (ORA) operations by serving as a confidential resource to improve communication channels, resolve disputes, and foster positive relationships with internal and external stakeholders.

Mission: To impartially address, investigate, and resolve concerns, disputes, and other issues that arise between the Office of Regulatory Affairs (ORA) and stakeholders outside of the U.S Food and Drug Administration (FDA), including industry, governmental organizations (local, state, federal, territorial, and tribal), and other members of the public in an informal and neutral manner.

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What is an Ombudsman?

An Ombudsman is a neutral, impartial person who investigates and settles disputes and resolves complaints. The Office of Regulatory Affairs (ORA) Ombudsman’s Office serves as a one-stop-shop for informal advice or consultation for external stakeholders who have complaints or inquires.

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What does the ORA’s Ombudsman do?

The ORA Ombudsman is dedicated to two primary objectives:

  1. Informally address concerns, complaints, and other issues that arise between ORA and stakeholders outside of the Agency, including industry, governmental organizations (federal, state, territorial, and tribal), and other members of the public; and
  2. Engage in outreach and education for these stakeholders and employees of ORA to enhance communication and transparency with stakeholders.

The ORA Ombudsman abides by ethical principles and standards established by the Coalition of Federal Ombudsmen, the U.S. Ombudsman Association, and the International Ombudsman Association. These include standards for ensuring confidentiality, neutrality, and informality.

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Why should you contact the ORA Ombudsman?

Interactions with the FDA can sometimes be confusing, daunting, and complicated. Occasionally, miscommunication occurs because the two sides aren’t speaking the same language. The ORA Ombudsman helps mitigate these factors between ORA staff and external parties without those parties fearing adverse administrative or retaliatory consequences. When disputes arise, the office is a sounding board that will listen to concerns and solve problems.

The Ombudsman provides knowledgeable, comfortable, and confidential (within legal constraints) information and advice on the regulatory process. As an unbiased arbiter, the office will serve as an effective translator, to ensure that each party understands possibilities and limitations.

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What kinds of issues does the ORA Ombudsman handle?

The Ombudsman’s Office will listen to your complaints, questions, and comments regarding (but is not limited to):

  • Import detentions and refusals;
  • Concerns about facility inspections;
  • Interactions with District Offices or ORA personnel;
  • Interactions with the Office of Criminal Investigations; and
  • ORA laboratory analytical findings and review.

The ORA Ombudsman will also answer your general questions about the ORA process and hear your ORA-related suggestions for improvements.

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Contact ORA Ombudsman

844-871-4536 (toll free) 


Erica Katherine, ORA Associate Ombudsman

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