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Draft guidance on good importer practices provides convenient checklist

This article was originally published in The Gold Sheet

Executive Summary

One of the Bush administration's parting gifts was a Jan. 12 guidance document that FDA drafted on behalf of itself and seven other federal agencies setting forth good importer practices for industry to follow. The guidance was the latest in a series of outputs from the Interagency Working Group on Import Safety, which President Bush established by executive order in July 2007 after the U.S. imported from China toys with lead-based paint, toothpaste with diethylene glycol and pet food with melamine and related chemicals. The working group is pressing for a paradigm shift from border control to product lifecycle risk management. The guidance provides a broad-ranging checklist for importers in four main areas: establishing a product safety management program; knowing the product and applicable U.S. requirements; verifying product and company compliance with U.S. requirements throughout the supply chain and the product life cycle; and taking corrective and preventive action when the imported product is not in compliance with U.S. requirements. The guidance is online at www.regulations.gov, where comments are due April 13 (reference Docket No. FDA-2009-D-0675)
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