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'Significant Number' of FDA Facility Registrations not Renewed, says CBP

A significant number of Food and Drug Administration food facility registrations that were not renewed by Jan. 31 are currently in the process of being modified to an invalid status by FDA, said CBP in a CSMS message. 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., it said.

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FDA continues to encourage import filers who file prior notices for food shipments to “take proactive action” and contact clients with high-volume food shipments, inquire about the FSMA food facility registration renewal status of foreign manufacturing facilities associated to their shipments, and confirm any new registration numbers, CBP said. Doing so could greatly mitigate any import food shipment delays related to food facility registration, it said.

CBP said ABI prior notice transaction rejections indicating a transmitted food facility registration (FFR(s)) is invalid may occur. When this happens, contact the individual providing the information and request updated food facility registration information for correction, it said.

CBP included a review of FDA registration reject reason codes sent by FDA. The registration codes appear in the BN application, FD02 record in position 65. Codes R, F, M, I, and C all indicate invalid registration as follows:

  • R = missing registration.
  • F = registration not on file. "F" will be returned when the number provided via the “PFR” affirmation of compliance is not and has never been on file
  • M = mismatch in registration. "M" is returned when there is a mismatch between the registration number and the firm transmitted as the manufacturer in the FD01 record.
  • I = invalidated registration.
  • C = canceled registration.

More information on FDA food facility registration is available here. For help with registration issues, contact FDA Industry Systems Help Desk at 800-216-7331 or 301-575-0156. For assistance via email, use the form on FDA’s website here.