VENEZIANO CONSULTING LLC
Domenic is an Independent FDA Regulatory and Strategic Consultant. A 24 year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), Domenic served as a senior FDA leader with 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 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 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 specializing in the medical device area. He was selected as a Supervisory Investigator where he was responsible for the oversight of the Medical Device team, assessing their inspectional reports, evaluating their findings and the evidence supporting them and endorsing the classification. 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 create and operationalized the Prior Notice Center in two short months 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 import products into the US and get them removed from import alert; evaluate medical device and 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.
University of Maine (BS, Engineering)
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