FDA Import Alerts: What They Mean and How to Resolve Them
Webinar 1.5 CCS
Import alerts are used to red flag imported FDA-regulated products and shift the burden of demonstrating admissibility to the importer (or manufacturer, distributor, etc.). An import alert can mean heavy compliance costs, significant delays in product release and business disruption, not to mention loss of goodwill from current or prospective customers concerned about noncompliance. This webinar will address how to avoid having an item placed on, and how to effectively get an item removed from, an FDA import alert.
- overview of import alerts
- obligations to learn when an import alert is issued
- implications of import alerts, including FSMA requirements
- seeking removal of an import alert
Shelly Garg is an attorney with Sandler, Travis & Rosenberg’s Food and Drug Law 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. Her keen insights into the FDA and its inner workings have proven to be of significant value to her clients in successfully resolving matters before the agency.