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

Description

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).

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Stakeholders

1

importer

Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for

Regulatory Context

Regulatory Activities

1

Foreign Supplier Verification Programs

FSVP regulation requirements for importers

Attributes

1

electronic mail address

FSVP importer must also provide the importer's name and electronic mail address

Standards & References

External Standards

1

FDA Food Safety Modernization Act

implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353)

Related CFR Sections (2)

21CFR1.509§ 1.509 How must the importer be identified at entry?
(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entryRead full regulation →
21CFR1.500§ 1.500 What definitions apply to this subpart?
The following definitions apply to words and phrases as they are used in this subpart. Other definitions of these terms may apply when they are used in other subparts of this part .Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Did not develop, maintain, and follow an FSVP

9

Failure to develop, maintain, and follow an FSVP

7

Failure to develop an FSVP

3

Did not develop an FSVP for any of the foods you import

2

Failure to conduct a written hazard analysis

2

Failure to determine and document verification activity frequency

1

Failure to verify and document production in accordance with 21 CFR part 113

1

Failure to provide a valid unique facility identifier

1

Failure to approve foreign suppliers based on evaluation

1

Failure to develop, maintain, and follow a FSVP

1