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Wednesday, August 11, 2010

FDA to Inspect Foreign Firms


I hope this brief update finds you well.  Here in the US Summer’s heat is unrelenting and FDA is turning up the heat also.

I learned today that FDA has issued letters to foreign food facilities that they will be inspected between October 1, 2010 and September 30, 2011. What does this mean for you? 

If you are outside the US and you manufacture, warehouse or distribute food or dietary supplement products that are imported to the US, you must respond to the FDA letter or risk having your registration terminated and any imports detained at the border.  You will only receive such a letter if you are properly registered. 

If you are outside the US and are not properly registered, this move on the part of FDA could mean that your products are immediately subject to detention since FDA has announced their intention to enforce the facility registration requirement.

If you are a US company but use imported ingredients or sell imported products, your purchases may be subject to detention if your supplier / manufacturer is not registered.

The registration process is simple and can be completed online by following this link:

FDA does not charge a fee for facility registration but you must provide the following information:
  1. Facility name, address, phone number, and emergency contact phone number
  2. Parent company name, address, and phone number (if applicable)
  3. Name, address, and phone number of the owner, operator, or agent in charge
  4. All trade names the facility uses
  5. Applicable food product categories, as listed on the registration form
  6. Name, address, and phone number of a foreign facility’s U.S. agent, and phone number of the facility’s emergency contact if it is someone other than the U.S. agent
  7. Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so
At your request, I would be pleased to send you a PDF copy of the Registration form that you may mail or fax to FDA along with an electronic booklet describing the process.  If you need help with your registration, the team at Bioscience Translation & Application can help.  We can facilitate the registration process, serve as your US agent and help you with other communications with FDA. Visit us at

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