CSMS# 17-000104 - FDA Prior Notice Rejection due to Registration Invalidation
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02/24/2017 02:45 PM EST
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Title: FDA Prior Notice Rejection due to Registration Invalidation
To: All Filers
From: Food & Drug Administration
Related CSMS Message: 16-001052, 16-000984, 17-000078
Filers of Prior Notice receiving rejections due to registration invalidations should consult the following for possible resolution:
• Registrations that have had a change in status
o Verify the status of the registration within the manufacturers FURLS Food Facility Registration Module (FFRM) account
o Verify the status of the registration with the third party that filed the food facility registration on the manufacturer’s behalf.
o Verify with the manufacturer that they are willing to be registered and inspected by the US Food and Drug Administration.
o Verify the owner, operator, or agent in charge listed in the registration is still in that current position and employed by the manufacturer.
o To facilitate communication with FDA, verify the owner, operator, or agent in charge has current valid contact information including a valid email address listed in the food facility registration.
o Verify the owner, operator, or agent in charge has confirmed the submission of the registration if filed by a third party or is a US manufacturing facility.
To confirm the receipt notification, the owner operator, or agent in charge must create an online FURLS account and follow the instructions for the owner operator, or agent in charge at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm084398.htm#confirm.
Owner, operator, or agent in charge confirmation can only be completed electronically
• U.S. Agent Verification Process
o Manufacturer or registrant needs to verify the U.S. agent in charge listed in the registration is still in that current position and agrees to be the U.S. Agent.
o Manufacturer or registrant needs verify the U.S. agent has current valid contact information including a valid email address listed in the food facility registration.
o Manufacturer or registrant needs to verify the U.S. agent has agreed to serve and confirmed the listing on the registration of a foreign facility.
To confirm the listing, the U.S. agent must create an online FURLS FFRM account and follow the instructions for the U.S. agent at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm084398.htm#confirm.
US agent confirmation can only be completed electronically.
If your entry is in reject status due to invalid registration, perform a CA Correction (PGA correction / update). Filing a duplicate entry for the shipment without resolving the original entry rejection will cause a delay in the release of the shipment. A cancellation of the rejected entry will cause a review of the shipment by CBP and/or FDA to determine if registration requirements are being circumvented.
Manufacturers should contact the FURLS Help Desk at FURLS@fda.gov or call 1-800-216-7331 to verify the current status of your food facility registration. Due to the high call volume, please expect long wait times for phone calls. You may also access the Food Facility Registration Module (FFRM) to verify the status of your registration.
Trade may contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries to verify the rejection reason.
Trade may also contact the Division of Food Defense Targeting at prior.notice@fda.hhs.gov or 866-521-2297 for assistance with valid food registrations verified by the FURLS Help Desk that may be rejecting improperly.
Related CSMS No. 17-000078, 16-000984, 16-001052
Note that supplemental information to this message is available in the form of one or more file downloads.
Please follow the link in this email message to the CSMS web site to access this information.
Title: FDA Prior Notice Rejection due to Registration Invalidation
To: All Filers
From: Food & Drug Administration
Related CSMS Message: 16-001052, 16-000984, 17-000078
Filers of Prior Notice receiving rejections due to registration invalidations should consult the following for possible resolution:
• Registrations that have had a change in status
o Verify the status of the registration within the manufacturers FURLS Food Facility Registration Module (FFRM) account
o Verify the status of the registration with the third party that filed the food facility registration on the manufacturer’s behalf.
o Verify with the manufacturer that they are willing to be registered and inspected by the US Food and Drug Administration.
o Verify the owner, operator, or agent in charge listed in the registration is still in that current position and employed by the manufacturer.
o To facilitate communication with FDA, verify the owner, operator, or agent in charge has current valid contact information including a valid email address listed in the food facility registration.
o Verify the owner, operator, or agent in charge has confirmed the submission of the registration if filed by a third party or is a US manufacturing facility.
To confirm the receipt notification, the owner operator, or agent in charge must create an online FURLS account and follow the instructions for the owner operator, or agent in charge at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm084398.htm#confirm.
Owner, operator, or agent in charge confirmation can only be completed electronically
• U.S. Agent Verification Process
o Manufacturer or registrant needs to verify the U.S. agent in charge listed in the registration is still in that current position and agrees to be the U.S. Agent.
o Manufacturer or registrant needs verify the U.S. agent has current valid contact information including a valid email address listed in the food facility registration.
o Manufacturer or registrant needs to verify the U.S. agent has agreed to serve and confirmed the listing on the registration of a foreign facility.
To confirm the listing, the U.S. agent must create an online FURLS FFRM account and follow the instructions for the U.S. agent at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm084398.htm#confirm.
US agent confirmation can only be completed electronically.
If your entry is in reject status due to invalid registration, perform a CA Correction (PGA correction / update). Filing a duplicate entry for the shipment without resolving the original entry rejection will cause a delay in the release of the shipment. A cancellation of the rejected entry will cause a review of the shipment by CBP and/or FDA to determine if registration requirements are being circumvented.
Manufacturers should contact the FURLS Help Desk at FURLS@fda.gov or call 1-800-216-7331 to verify the current status of your food facility registration. Due to the high call volume, please expect long wait times for phone calls. You may also access the Food Facility Registration Module (FFRM) to verify the status of your registration.
Trade may contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries to verify the rejection reason.
Trade may also contact the Division of Food Defense Targeting at prior.notice@fda.hhs.gov or 866-521-2297 for assistance with valid food registrations verified by the FURLS Help Desk that may be rejecting improperly.
Related CSMS No. 17-000078, 16-000984, 16-001052
Note that supplemental information to this message is available in the form of one or more file downloads.
Please follow the link in this email message to the CSMS web site to access this information.
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