FDA Import Alerts Webinar – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–“FDA’s Import Alerts Webinar” has been added to from ResearchAndMarkets.com offer.

This webinar will provide attendees with background information on FDA Import Alerts, discuss why they are a problem, where to locate them, how to tell if a company or product is under an Import Alert, and finally , will provide a series of strategic recommendations for getting out of an alert.

An import alert allows the FDA to detain, without physical examination, products that violate, or could potentially violate, the Food, Drug, and Cosmetic Act (“FDC Act”). Import alerts let FDA field personnel know that the agency has enough evidence or other information to deny admission to future shipments of an imported item. There are a variety of factors that could cause the FDA to place a product, manufacturer, shipper, producer, geographic area, and/or country on Import Alert.

Once a shipment is denied entry into the United States, the importer has the opportunity to present evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held in a warehouse or on the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days.

The alert can be issued for an import from a manufacturer, shipper, producer, geographic area or country. If the problem or condition exists on a large scale, federal inspectors would be responsible for detaining all products of a certain type from that country.

An imported product, company, region, or country may retain this status until evidence or other information is provided that satisfies the FDA that the shipment is safe for consumers and that the future shipments will comply with the law. The conditions that the importer must meet vary according to the stipulations of the Import Alert.

learning objective

  • Understanding the nature of import alerts: what are they? What are they for? What do they mean for a business?

  • Familiarize yourself with the shared jurisdiction of CBP and FDA in US ports.

  • Company or products to add to an import alert.

  • Be able to find and search the FDA Import Alerts database.

  • Understand the potential and actual impact of being named on an FDA import alert.

  • Be able to identify the steps for removing a company or product from an import alert.

  • What to do if you learn that your products are being held by the FDA at a port and your company name is added to an import alert.

Takeaway webinar

  • Import alerts

  • The Different Types of Import Alerts Issued by the FDA

  • Why is a country, company or products added to an import alert?

  • What impact does being named on an import alert have on a business

  • What to do if your products are held or held in port by the FDA.

  • What to do if your business or products are named in an import alert.

  • Strategic recommendations for removing your company and/or products from an import alert.

Who should attend:

  • Regulatory affairs professionals, managers, consultants, scientists, research analysts, state policy officials, insurers focusing on assurance of representations and warranties; investment analysts; Venture capitalist.

  • Pharmaceutical, biological, animal health, food, medical device and other biotechnology companies

  • Domestic and foreign companies, small businesses, start-ups, product manufacturers, importers, labelers and distributors

  • Importers, customs brokers, distributors

  • Financial analysts and investors monitoring the pharmaceutical, life sciences and biotech industries

For more information on this webinar, visit https://www.researchandmarkets.com/r/irrzs4

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