Prior Notice Errors Could Be Due to Improper FDA Registration Renewal
The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) requires all food and beverage manufacturers to renew their FDA food facility registration by December 31, 2012. Due to system delays, FDA exercised enforcement discretion with food facility registration renewals, granting companies until January 31, 2013. Companies that were required to renew their food facility registrations under FSMA but have not done so must re-register.
Beginning in April 2013, companies exporting to USA without a properly renewed food facility registration began experiencing the following error message when filing Prior Notices with FDA:
You must correct the following before proceeding:
Unable to validate the Manufacturer Registration Number you have supplied. Please correct the information you have entered.
Further, when attempting to access a food facility registration in the FDA Food Facility Registration Module (FFRM) that was not properly renewed, users have reported receiving the following error message:
FAILED TO RENEW FOR PERIOD 2012
The registration you are attempting to update cannot be accessed because it was not renewed during the 2012 renewal period. Section 415(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d(3)] requires food facilities that are required to register with FDA to renew their registrations every other year. Please click on the continue button to re-register your facility.
FDA released new non-binding draft guidance for staff in April regarding the food facility registration renewal deadline set in FSMA. FDA’s new Guidance for FDA Staff document states that companies that failed to renew their food facility registration within the appropriate timeframe have “committed a prohibited act under section 301 (dd) of the FD&C Act.” Read more about the FDA draft guidance for staff.
Registrar Corp is a FDA regulatory compliance firm that assists companies with their Food Facility Registrations, Renewals, and U.S. Agent requirements. Registrar Corp can help your company re-register with the FDA. Re-register your FDA Food Facility Registration now. Registrar Corp’s Food Safety Department also performs Mock FDA Inspections of facilities to help companies prepare for U.S. FDA inspections. FSMA requires FDA to inspect foreign food facilities and to double the number of inspections every year until 2015. This year alone, FSMA requires FDA to perform a minimum of 2400 inspections of foreign facilities. Prepare now for a U.S. FDA inspection.
For more information about the Food Safety Modernization Act (FSMA) or any U.S. FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or phone Registrar Corp: +1-757-244-0177.