On August 9, 2014 the FDA’s United Registration and Listing System (FURLS) Food Facility Registration Module (FFRM) underwent system maintenance.
FFRM users now have the ability to edit a food facility’s name and address in previously submitted registrations.
In the past, FDA’s food facility registration system did not permit modifications to a facility’s name or physical address after a food facility registration was submitted to the FFRM. This restriction prevented users from making corrections to typographical errors after submission. Users had to cancel the registration and create a new registration (with a new registration number), even to make small changes. Now, users are able to correct typographical errors without creating a new registration. Users, however, must be very careful that they understand the FDA’s requirements regarding changes of ownership and/or physical address. For example:
21 CFR 1.234(b) states:
“If the reason for the update is that the facility has a new owner, the former owner must cancel the facility’s registration as specified in 1.235 within 60 calendar days of the change and the new owner must re-register the facility as specified in 1.231. The former owner may authorize an individual to cancel a facility’s registration.”
When a company ceases operations at a facility location and begins operation at a different facility location, that company is the new owner of the new facility. In order to comply with 21 CFR 1.234 (b), a change in a company’s physical address must be processed via a new registration.
FFRM includes a new feature to retrieve the PIN associated with a food facility registration number.
The new PIN retrieval feature in the main menu of the FFRM allows a user to retrieve a PIN by answering a series of five questions. Previously, FDA did not have an online means to retrieve a lost PIN so this update should be helpful to many users.
FFRM now requires the e-mail address for food facilities and their U.S. Agents to be different.
In addition to normal registration requirements, foreign food facilities must also designate a U.S. Agent for FDA communications. The U.S. Agent serves a different function than an importer, customs broker, commercial distributor, or trade association. FDA sends important communications to the U.S. Agent, including information regarding inspections. U.S. Agents are expected to be available twenty-four hours a day, for FDA often requires an immediate response.
Along with FDA communications, the U.S. Agent is responsible for certain administered reinspection fees. Beginning October 1, 2014, reinspection fees will be $217 USD an hour for domestic facilities and $305 USD an hour for foreign facilities. These fees apply to all direct hours spent on the reinspection, including travel to and from the facility. FDA often contacts a U.S. Agent via the e-mail address provided in a foreign facility’s FDA Registration.
The updated FFRM now prevents the registrant from proceeding with the registration if the e-mail addresses for the facility and the U.S. Agent are the same. This update prevents registrants from circumventing the important role of the U.S. Agent by listing the facility’s e-mail address for both. This e-mail update is especially important with the 2014 FDA registration renewal period approaching. Food facilities are required to renew their registration between October 1st and December 31st of each even numbered year. Any facility that currently lists the same e-mail address for both the facility and U.S. Agent will be required to change this before submitting their renewal. When a facility changes their U.S. Agent information, the new agent is given 15 days to accept responsibility. If they do not accept, the facility’s registration will become invalid and will need to be re-activated.
Registrar Corp acts as a U.S. agent for over 12,000 companies. We can serve as a reliable, well-informed U.S. Agent for food facilities. Along with communication services, Registrar Corp renews registration for clients and will even send a food safety expert trained in FDA inspections to facilities to help them prepare. If FDA gives notice of an inspection, Registrar Corp will perform the mock inspection for no additional cost other than travel and lodging expenses.
For questions regarding these changes and other FDA regulations, or to learn more about how Registrar Corp can assist your facility, contact us at 1-757-224-0177 or receive online Live Help from our regulatory specialists: https://www.registrarcorp.com/livehelp.