Domenic J. Veneziano is an Independent FDA Regulatory and Strategic Consultant and Owner of Veneziano Consulting, LLC. A 24 year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), Domenic served as the Director of Import Operations in the Office of Regulatory Affairs. As a senior FDA leader he had prominent roles in the oversight of FDA’s National import operations program, including the development and implementation of FDA’s Targeting System PREDICT and the Import Trade Communication System (ITACS), the integration of Customs and Border Protections Automated Commercial
Environment (ACE) with FDA’s systems, and the new Food Safety Modernization Act (FSMA) and Food and Drug Safety and Innovations Act. He was recognized as FDA’s expert in import operations and as such has testified in federal court and before Congress, has initiated, approved, and endorsed enforcement actions, has represented the FDA for media inquiries, represented FDA on White House initiatives, the Automated Commercial Environment/International Trade Data System board of directors and the Border Interagency Executive Council. Additionally, Domenic has been the recipient of numerous awards, including the Department of Human Services Secretary’s Award for Distinguished Service.
Domenic began his FDA career as a field investigator in the New England District office where he conducted domestic and foreign inspections and investigations. He was selected as a Supervisory Investigator where he was responsible for assessing inspectional reports, evaluating documented violations and the evidence supporting them and endorsing the classification of the inspection. He was also responsible for the New England Districts import program.
In 2003, Domenic transferred to FDA Headquarters when he was asked to establish, staff and Direct FDA’s first 24/7/365 operational center in response to the Bioterrorism Act of 2002. Domenic created and operationalized the Prior Notice Center and served as its Director for 2 years. In 2005, Domenic became the Director of the Division of Import Operations and Policy where he enforced the import laws, developed and implemented field operational policy and procedures across the country covering over 320 port of entries, and advised FDA Senior Executives on all issues related to import operations.
As a consultant, Domenic will work closely with clients to provide advice to producers, importers, exporters and distributors of FDA-regulated commodities; help clients register with the FDA, import products into the U.S. and get them removed from import alert; evaluate food facilities to determine compliance with good manufacturing practice regulations and the FSMA; and to assist in correcting deviations found during FDA inspections or third-party audits.
