CSMS Message: 13-000621

From: FDA

As previously communicated under CSMS# 13-000020, CSMS #13-000044 & CSMS #13-000097, the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. Among many other changes, FSMA amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d], which requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA. Under FSMA, all food facilities that are required to register with FDA under section 415 of the FD&C Act must renew their registration with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.

As mentioned in CSMS# 13-000020, CSMS #13-000044 & CSMS #13-000097, if a foreign food facility is required to register with FDA, but failed to do so, food from that facility imported or offered for import into the U.S. is subject to refusal under section 801(l) of the FD&C Act. Please note that a significant number of food facility registrations (FFRs) that were not renewed by January 31, 2013 have been modified to an “INVALID” status by FDA. As a result, imported food shipments manufactured by those facilities without valid registrations may be held at the port or refused upon arrival in the U.S. FDA advises filers who file prior notices for food shipments and receive a prior notice rejected message to note the reject reason code. In the case where code “I” is observed, please contact the individual providing the Food Facility Registration information, and request the new/renewed FFR information for correction. Doing so could greatly mitigate any import food shipment delays related to food facility registration.

A brief review of the FDA registration reject reason codes sent by FDA via ABI:
The registration codes appear in the BN application, FD02 record in position 65.

R, F, M, I, C invalid registration
R = missing registration
F = registration not on file
M = mismatch in registration
I = invalidated registration
C = cancelled registration

"F" will be returned when the number provided via the “PFR” affirmation of compliance is not and has never been on file

"M" is returned when there is a mismatch between the registration number and the firm transmitted as the manufacturer in the FD01 record.

"I" means that FDA has invalidated the registration

"C" means the registration has been cancelled

For ABI BN record layout information above, refer to the Customs and Trade Automated Interface Requirements (CATAIR) document, Other Government Agencies chapter, page OGA 37, or consult your ABI software provider. CATAIR chapters available here:
www.cbp.gov/xp/cgov/trade/automated/automated_systems/abi/catair/chapters/
Select the Other Government Agencies chapter.

For more information on the FDA food facility registration requirement, see FDA's website at
http://www.fda.gov/Food/guidanceregulation/FSMA/ucm314178.htm

For assistance with registration issues contact FDA Industry Systems Help Desk at 800-216-7331 or 301-575-0156. For assistance via email, utilize the form on FDA's website http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm