The FDA Ombudsman
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.
- 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.
- Coordination of Requests for Reinstatement by disqualified clinical investigators.
Laurie Lenkel, Director
Andrew Moss, Deputy Ombudsman
Talisha Williams, Paralegal Support Specialist
Phone: (301) 796-8530
Fax: (301) 847-8628