How to Use Foreign Trade Zones and Bonded Warehouses in the U.S.
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He conducted domestic and foreign inspections. He specialized in the FDA’s food and medical device programs as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for regulatory guidance and government operations. He developed enforcement actions and participated in the implementation of new statutory requirements, such as FDA’s import/export program. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how the FDA thinks, operates and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.
The use of Foreign Trade Zones and Bonded warehouses for FDA regulated products create different opportunities and different obligations. Firms need to understand the requirements of each to use them to their advantage. The imported products will have different regulatory requirements depending on the option chosen. In some cases, the FDA does not give you an option and the outcome is expensive. Firms also must consider the physical security and controls of their products. Theft, loss, damage or diversion must be factored into your decisions. Your choices need to consider the risks posed by using one approach versus another. Your cargo shipment may be very valuable and should be treated as such.
The webinar covers how the use of Foreign Trade Zones and Bonded Warehouses to your advantage and what obligations there are for FDA and the U.S. Customs and Border Protection service (CBP.) There are pros cons to using each, and there are different regulatory requirements for CBP and FDA. Some imported products will never have an easy path.
- The role of Foreign Trade Zones (FTZ)
- The role of Bonded Warehouses
- The Food and Drug Administration’s regulatory role
- Customs and Border Protection regulatory controls
- Product security
- Record keeping
- Managing Bulk Active Pharmaceutical Ingredients
- Pros and Cons of using FTZs and Bonded Warehouses
Who Should Attend
- Initial Importers of FDA regulated products
- Owner of Record for Entries
- FDA registered U.S. Agents
- Import Logistics Managers
- Foreign Manufacturers
- U.S. Manufacturers
- Import-for-export Manufacturers
- Customs Brokers
Why Should Attend
You can save time and money by using Foreign Trade Zones and Bonded Warehouses wisely. There are regulatory and practical business considerations for using either option. Depending on which service you use, you must be prepared to the regulatory controls and consequences of the federal government.
You will be able to:
- Apply criteria to determine what kind of storage or manufacturing options you have
- Prepare appropriate procedures and records for the FDA and CBP
- Make more informed decisions about the consequences of your decisions
- Develop logistical strategies based on your product pipeline