GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a two-day, in person, live seminar on the topic, “FDA and U.S. Customs Import Rules and Export Traps in 2020”, on December 4 and 5.
Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, will be the Director of this seminar. Please enroll for this session by visiting https://www.globalcompliancepanel.com/seminar/tougher-import-rules-for-FDA-901966SEMINAR
Smarter, more sophisticated, more agile and more demanding. These are what the FDA and the Customs and Border Patrol Service (CBP) have become of late when it comes to their expectations and requirements from importing firms of the submission of information and adherence to government procedures. Firms that fail to properly execute an import and export program can expect the FDA and the CBP to delay, detain or refuse their shipments.
The new Automated Commercial Environment (ACE) computer program from the CBP has brought in many changes to the process of import logistics and information reporting for FDA regulated products. As a result, companies that do not comply with the requirements set out in the ACE program can experience one of the worst nightmares they can think of: having their shipment stopped before it is even loaded at the foreign port! And then, if they refuse to or fail to use the ACE program, such ships also carry a fine of up to $10,000 for every offense.
There is more: such companies whose products the FDA detains face a cumbersome, long winding and expensive legal process. The FDA expects companies to have the import coding information accurate and up-to-date. Any company that lacks a thorough and clear understanding of the automated and human review process are almost certain to have their shipments detained.
And then, what happens in a scenario in which the FDA decides that importers should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold? Well, in such instances, such companies are slapped a fine that is three times the value of the shipment, not to speak of the additional adverse legal concerns and strategies that come along.
What do all these mean? Simple: if you are an importer, you are doomed if you fail to comply with the FDA’s guidelines on imports.
Yet, there is a way out of this quagmire, in the form of the Voluntary Qualification Importer Program, which the FDA is implementing under the FDA Food Safety and Modernization Act. This plan seeks to reward importers who demonstrate a level of confidence about the quality of food they import by establishing an FDA-supervised, fee-based program. What this program does is that it facilitates the review and importation of foods from importers who establish a higher level of control over the safety and supply chain aspects of the imported food items.
And then, there is also the extra perk that the FDA offers: its export certificates. Offered at a reasonable fee; these certificates can go a long way in giving an importer a competitive advantage in foreign markets. In fact, a few foreign governments make an FDA export certificate a requirement.
The aim of this seminar is to offer learning on all these core areas of the FDA and US Customs Import Rules in 2020. The Director will explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products. The learning will be taught over the following agenda:
Day 1 Schedule
FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation
FDA Import Process (continued)
- Import Brokers
- Prior Notice Information
- CBP and FDA computer programs
- Import Codes
- Bonds and Bonded Warehouses
- FDA “Notice of Action”
Import Delays Import Alerts Detention Refusals
Day 2 Schedule
Foreign Inspections FDA 483 – Inspectional Observations
FDA Warning Letters and Automatic detention
Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical
FDA Export Program Special Import Issues
- Trade Shows
- Personal Use
- Compassionate Use