Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation

Description

This guidance provides information on the requirement under theForeign Supplier Verification Programs for Food Importers(FSVP) regulation for the importer of a food to ensure that for each entry line of food offered for importation into the United States the unique facility identifier (UFI) recognized as acceptable by FDA for importer identification is provided electronically when filing entry with U.S. Customs and Border Protection (CBP). The UFI initially recognized as acceptable by FDA for importer identification is a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number. The pronoun “you” is used in this guidance to refer to the FSVP importer as defined in the FSVP regulation (21 CFR1.500).

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

1

Food

articles used for food or drink for man or other animals

Stakeholders

2

FSVP importer

The entity responsible for developing and implementing an FSVP.; entity responsible for foreign supplier verification

Importer

Must comply with registration if meeting facility/responsible person definitions

Regulatory Context

Regulatory Activities

2

FSVP

Foreign Supplier Verification Program requirements for importers; Foreign Supplier Verification Programs; Foreign Supplier Verification Programs design and implementation; Foreign Supplier Verification Programs regulation; Foreign Supplier Verification Programs requirements.; Foreign Supplier Verification Programs.; Foreign Supplier Verification Programs requirements for importers; Foreign Supplier Verification Programs for importers; Foreign Supplier Verification Programs compliance evaluation

Entry Filing

Electronic submission of data to CBP

Document Types

1

FSVP records

the location at which you maintain your FSVP records.

Related CFR Sections (4)

21CFR1.510§ 1.510 How must I maintain records of my FSVP?
(a) General requirements for records.Read full regulation →
21CFR1.501§ 1.501 To what foods do the requirements in this subpart apply?
(a) General. Except as specified otherwise in this section, the requirements in this subpart apply to all food imported or offered for import into the United States and to the importers of such food.Read full regulation →
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

104

Failure to develop, maintain, and follow an FSVP

77

Failure to develop an FSVP

24

Failure to conduct a hazard analysis

17

Failure to perform foreign supplier verification activities

13

Failure to conduct a written hazard analysis

10

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

9

Failure to evaluate foreign supplier performance

8

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

8

Failure to approve foreign suppliers based on evaluation

7