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U.S. Department of Health and Human Services

About FDA

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Resources for FDA Regulated Businesses

The U.S. Food and Drug Administration strives to protect, promote and enhance the health of the American people, while minimizing the regulatory burden on the industries it regulates.  You have a right to disagree with any agency decision, action, or operation without fear of retaliation.  You also have a right to be treated with appropriate courtesy and respect.  If you are dissatisfied with any agency decision or action, you may appeal to the supervisor of the employee who made the decision or took the action.  If the issue is not resolved at the first supervisor’s level, you may request that the matter be reviewed at the next higher supervisory level.  This process may continue through the agency’s chain of command.

To resolve a problem with your company’s interaction with FDA, or if you have questions or concerns about FDA rules or procedures, we suggest that you first write or call your District Office to explain your concerns.  If you are not satisfied with the help provided by the District Office, you may take your complaint or concern to the Regional Office.  If that effort is not satisfactory, contact the FDA’s Office of the Ombudsman for further assistance and guidance.

Contact the District Office if you have a concern or question about an inspection, an import or export issue, or any other action taken by an FDA field representative.  The District Office will provide you with the name and phone number of someone who will review the matter and provide assistance.

Baltimore410-779-5454New England781-596-7700
Chicago312-353-5863New Jersey973-331-4900
Cincinnati513-679-2700New Orleans615-366-7801
Dallas214-253-5200New York718-340-7000
Detroit313-393-8100San Francisco510-337-6700
Florida407-475-4700San Juan787-474-9500
Kansas City913-752-2100Seattle425-486-8788
Los Angeles949- 608-2900Southwest Import214-253-5330

Contact the Regional Office for further help if you are not able to effectively resolve the issue with the assistance of the district office.  Telephone numbers for the regional offices can be found at http://www.fda.gov/ICECI/Inspections/IOM/ucm124008.htm.

Contact the FDA Office of the Ombudsman at 301-796-8530 or via e-mail at OMBUDS@OC.FDA.gov

The Small Business Administration also has an ombudsman. The SBA National Ombudsman.  If you wish to comment on the enforcement actions of FDA, call 1-888-734-3247.  The SBA National Ombudsman’s homepage can be found athttp://www.sba.gov/aboutsba/sbaprograms/ombudsman/index.html.