The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: April 29, 2021 at 8am to April 30, 2021 at 2pm
Location: Online event
Street: Online event
Website or Map: https://www.gcplearning.com/v…
Event Type: online, event
Organized By: John Robinson
Latest Activity: Apr 12
FDA’s import and export programs are complex, detailed and undergo changes without notice to the public. The FDA’s and CBP’s new import and enforcement programs operate with remarkably efficient software systems that can leave a firm scrambling for a resolution and end up suffering the expensive consequences of a detention. The information data base used by the FDA includes extensive information from foreign suppliers. If that is not in order, your shipment will not be permitted entry, in some cases even before the products can be loaded onto the vessel in a foreign port or before it arrives at the U.S. port.
Foreign establishments are subject to the same manufacturing regulations as U.S. firms. There are inherent problems with foreign commerce, such as language and cultural differences. If a foreign firm’s manufacturing operation or its products fail any criteria, a detention, or even worse, a refusal, becomes your next crisis. If your product is detained, you must now how to try and resolve the problem with the FDA. You have only ten days to figure out your plan and have FDA agree, which as not a given. On day 11, your product must either be destroyed or exported.