CSMS# 17-000255 - Update to FDA Foreign Supplier Verification Program (FSVP) Data Requirements
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Update to FDA Foreign Supplier Verification Program (FSVP) Data Requirements
Transmission of Foreign Supplier Verification Program data becomes mandatory May 30, 2017. Among the mandatory ACE data elements is the Unique Facility Identifier (UFI) for the FSVP Importer. FDA recognizes the DUNS as a UFI acceptable to FDA, and FDA expects the transmission of the FSV Importer’s DUNS number in this field in PG19.
This will be available in ACE Certification for testing on or before May 11, 2017. A CSMS will be issued to confirm deployment to ACE Certification.
For the onboarding period, FDA will temporarily allow the submission of “UNK” (unknown) as the syntax for the DUNS number for the FSV Importer in PG19. “UNK” should only be used if the nine-digit, site-specific DUNS number is not available at the time the entry is transmitted.
A CSMS will be issued at a later date to indicate when UNK will no longer be accepted.
To obtain a DUNS number for free, visit www.fdadunslookup.com. DUNS numbers should be unique for each firm, i.e., a corporate headquarters with multiple company locations should not have the same DUNS number for each site. Each unique site (address) should have a unique DUNS number.
Please note: There are no additional changes to the required data elements for the Foreign Supplier Verification Program Importer.
For a list of specific data elements required for FSVP, refer to the FDA Supplemental Guide V2.5: https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16
For questions related to FSVP, please contact FDA at the following link: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.
For questions related to the submission of data elements for FSVP contact FDA’s ACE Support, 6:00 AM to 10:00 PM, 7 days a week at: ACE_Support@fda.hhs.gov, 877-345-1101, or 571-620-7320.
Update to FDA Foreign Supplier Verification Program (FSVP) Data Requirements
Transmission of Foreign Supplier Verification Program data becomes mandatory May 30, 2017. Among the mandatory ACE data elements is the Unique Facility Identifier (UFI) for the FSVP Importer. FDA recognizes the DUNS as a UFI acceptable to FDA, and FDA expects the transmission of the FSV Importer’s DUNS number in this field in PG19.
This will be available in ACE Certification for testing on or before May 11, 2017. A CSMS will be issued to confirm deployment to ACE Certification.
For the onboarding period, FDA will temporarily allow the submission of “UNK” (unknown) as the syntax for the DUNS number for the FSV Importer in PG19. “UNK” should only be used if the nine-digit, site-specific DUNS number is not available at the time the entry is transmitted.
A CSMS will be issued at a later date to indicate when UNK will no longer be accepted.
To obtain a DUNS number for free, visit www.fdadunslookup.com. DUNS numbers should be unique for each firm, i.e., a corporate headquarters with multiple company locations should not have the same DUNS number for each site. Each unique site (address) should have a unique DUNS number.
Please note: There are no additional changes to the required data elements for the Foreign Supplier Verification Program Importer.
For a list of specific data elements required for FSVP, refer to the FDA Supplemental Guide V2.5: https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16
For questions related to FSVP, please contact FDA at the following link: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.
For questions related to the submission of data elements for FSVP contact FDA’s ACE Support, 6:00 AM to 10:00 PM, 7 days a week at: ACE_Support@fda.hhs.gov, 877-345-1101, or 571-620-7320.
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