FDA Facility Registration Renewal Begins Oct. 1

The next FDA facility registration renewal period is right around the corner. AFI staff members are already taking steps to ensure the process goes smoothly yet again for AFI foreign member firms using the association as their FDA registration agent. Some quick reminders about the process:

•  The renewal period runs Oct. 1 - Dec. 31. Renewing the registration prior to Oct. 1 does not eliminate the need to renew during the renewal period.
• Foreign facilities need to name a U.S. agent to serve as a communications conduit between the facility and FDA. AFI includes this service at no additional charge for one facility for all foreign members (additional facilities $150 each).
• For several reasons, it’s generally not a good idea for importers to serve as a facility registration agent.
• I firmly believe AFI is the best option as a facility registration agent because in addition to knowing the registration will be handled properly, the foreign supply will receive all the information AFI sends out, be listed in AFI member directories, have access to all other AFI member benefits and be “associated” with leading U.S. importers.
• When the registration requirement was implemented, many AFI importer members encouraged their suppliers to have AFI be their facility registration agent. We’d appreciate importers reminding suppliers of this service and the benefits. Over the years, several importers have told me they prefer their suppliers to be members of AFI so they can be confident the facility registrations are handled properly and so they know their suppliers are up to date on U.S. regulations.
• Lastly, facilities in all countries will soon – if they haven’t already – begin to receive scary emails about this process, particularly from one company. We need to get people to disregard these emails. Unfortunately, some people will fall victim to this tactic and pay to create a new registration when the one they have in place is perfectly valid. Foreign suppliers, if you get one of these emails, please reach out to AFI and we’ll tell if you it’s something to be concerned about. U.S. members, get the word out to your foreign suppliers to ignore those emails. They are welcome to contact us as well; we’re happy to answer all questions.

The facility registration requirement is perhaps the easiest part of FDA compliance. Please let AFI help you avoid any headaches.

President's Letter Written by Bob Bauer, President, AFI