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www.fdanews.com/articles/129956-fda-asking-devicemakers-to-help-with-overseas-supply-oversight

FDA Asking Devicemakers to Help With Overseas Supply Oversight

September 1, 2010
The FDA is trying to stretch its enforcement reach over foreign device suppliers, potentially through consent decrees, and is asking manufacturers to take bigger steps as well to tighten the supply chain. Currently, the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations, but it is looking at other options, Carmelo Rosa, an FDA compliance officer, said.
Devices & Diagnostics Letter