Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation


How to Comment

Submit electronic comments on to docket number FDA-2011-N-0143.

Submit written comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2011-N-0143.

Contains Nonbinding Recommendations

March 2017

This guidance specifies FDA’s current thinking on what unique facility identifier (UFI) FDA recognizes as acceptable for purposes of the Foreign Supplier Verification Programs (FSVP) regulation established in Title 21 of the Code of Federal Regulation, Part 1, subpart L as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353).

The pronoun “you” is used in this guidance to refer to the importer.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.

Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 

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