Issue 9, January 20, 2009
The Food and Drug Administration (FDA) has posted a draft document entitled “Guidance for Industry, Good Importer Practices” to their website. The document is a guide for importers of goods that fall under FDA regulations and suggesting good practices and procedures for improving compliance with applicable U.S. FDA requirements. The FDA is accepting comments on the document until April 13, 2009.
This guide is intended both for importers of foreign originating products and for those re-importing U.S originating products. It is a guide to help importers establish procedures to insure compliance with all applicable U.S. FDA requirements. The procedures include knowing your foreign partners, understanding your product and the FDA requirements for them and being aware of any threats that the product may pose to health and safety. The guide helps importers in instituting practices and procedures to identify products under FDA jurisdiction, control movement, insure proper documentation and minimize risks, including those posed by accidents and the threat of attack.
The Good Importer Practices are grouped into four categories:
- Establishing a product safety management program
- Knowing the product and understanding the applicable U.S. requirements
- Monitoring and controlling compliance both during and after importation
- Changing procedures when necessary to insure compliance of the product
The guide, which spells out specific practices and procedures for each of these objectives, can be accessed at:
http://www.fda.gov/oc/guidance/goodimportpractice.html
For more information please contact your DHL Global Forwarding representative.
Sincerely,
Karl F. Krueger
Regulatory Compliance Consultant
Licensed Customs Broker
NCBFAA Certified Customs Specialist
