The U.S. Food and Drug Administration has issued notices to all foreign food facilities registered with the FDA that it will conduct an inspection of those facilities between October 1, 2010 and September 30, 2011. Foreign food facilities that manufacturer, process, pack, hold, and ship food to the United States must have registered with the FDA pursuant to the Bioterrorism Act. Foreign food facilities that do not properly respond to the FDA notices may have their registrations automatically terminated. In effect, that will result in a detention of any food that arrives in the United States from those canceled facilities.
It is no secret why the FDA is visiting foreign food facilities shipping food to the United States. See blog post “The FDA is Flexing Its Enforcement Muscles”. The Foreign Food Inspection Team at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) based in College Park, Maryland, is responsible for coordinating the foreign food inspections. The recent FDA notices state, in part:
The inspection will be conducted by an investigator of the FDA to determine if your facility is operating in accordance with U.S. Food, Drug, and Cosmetic Act and its regulations, including Title 21 CFR Part 110, Good Manufacturing Practices (GMP) regulations.
Any foreign food facilities not yet registered may register with the FDA using a website www.FDA-USA.com established and operated by my law firm for a fee. It is very easy to register on-line in English, Spanish, Portuguese, or German. Companies should properly prepare prior to the FDA inspection.
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