Preparing for and Managing FDA Foreign Supplier Verification Program Inspections
Webinar: 1 CCS Credit
The Food and Drug Administration’s Foreign Supplier Verification Program makes importers responsible for ensuring that their foreign suppliers use processes and procedures that provide at least the same level of public health protection as the FDA’s preventive controls or produce safety regulations. The FDA is increasing the number of inspections it conducts under the FSVP, but many food importers are unfamiliar with these types of inspections and uncertain how to prepare for them. This 60-minute webinar will review what importers should expect and how they can prepare for an FSVP inspection.
- background of FDA food inspections
- preparing for an FSVP inspection
- what happens at the end of the inspection
- enforcement implications and potential collateral consequences
- strategies for compliance
Shelly Garg is an attorney with Sandler, Travis & Rosenberg’s FDA Practice Group. She represents clients across a broad range of FDA-regulated product categories, including food, beverages and dietary supplements, over-the-counter drugs, medical devices, and cosmetics. She advises in strategic business planning, product development, testing and approval, labeling, advertisement and promotion, liability risk, inspections, responding to regulatory enforcement matters, and related issues.
Domenic J. Veneziano is a consultant for ST&R and works closely with ST&R’s FDA Practice Group to provide advice to producers, importers, exporters, and distributors of FDA-regulated commodities; to evaluate medical device and food facilities to determine compliance with good manufacturing practice regulations and the Food Safety Modernization Act; and to assist ST&R clients in correcting any deviations found during FDA inspections or third-party audits. A 24-year veteran of the FDA and U.S. Public Health Service, Mr. Veneziano 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 the PREDICT targeting system and the Import Trade Communication System, the integration of the Automated Commercial Environment with FDA systems, and the FSMA and Food and Drug Safety and Innovations Act.