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.
FDA Office of the Ombudsman
Laurie Lenkel, Director
Andrew Moss, Deputy Ombudsman
10903 New Hampshire Avenue
White Oak Building 1, Rm 4202Silver Spring, MD 20993