Customs Entry Process Under FSVP




FSVP IMPORTER'S DUNS NUMBER MUST BE TRANSMITTED BY FILER DURING U.S. CUSTOMS ENTRY



FDA has begun notifying importers and filers that have used “UNK”, to correct details. FDA's original intent was for the use of “UNK” to be temporary, while the FSVP Importer obtained a Data Universal Numbering System (DUNS). FDA plans to rescind its policy that allows for “UNK” in the near future.

Correct Entry Procedure Under FSVP: When a food, beverage, or supplement product is subject to FSVP, the filer responsible for U.S. Customs and Border Protection (CBP) entry must enter “FSV” as the Entity Role Code. This code will send a signal to CBP's Automated Commercial Environment indicating that the entry is subject to FSVP and will trigger a request for the FSVP Importer’s name, electronic email address, and UFI recognized as acceptable by FDA (§1.509). FDA currently recognizes the DUNS number as the only acceptable UFI for the purpose of compliance with FSVP.



PG19 FSVP Importer's DUNS, Entity Identifier Code [DUNS], Entity Number [DUNS], Business Name, and Street Address.

PG20 FSVP Importer's Street Address (Line 2), City, State, Country, & Zip Code. (FSVP Importer must be a U.S. domiciled entity, virtual companies do not qualify.)

PG21 Entity Qualifier ("FSV"), Individual's Name (or leave blank), FSVP Importer's Telephone, Email Address.

Important: The DUNS number, which is location specific, must correspond to the FSVP Importer’s U.S. location. FDA invFSVP IMPORTER'S DUestigators may conduct an inspection to review all FSVP records at the location associated with the DUNS number submitted at entry. A DUNS number associated with a foreign facility cannot be used for the FSVP Importer at U.S. entry.





DOWNLOADS & RESOURCES

 

FDA: Notice to FSVP Importers & Filers (Example)


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FDA: Notice to FSVP Importers & Filers (Example)





FDA: Recognition of Acceptable UFIs Guidance


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FDA: Recognition of Acceptable UFIs Guidance





FDA: Acceptable UFI Under FSVP Guidance


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FDA: Acceptable UFI Under FSVP Guidance





CBP: FDA to Validate FSV Email Syntax


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CBP: FDA to Validate FSV Email Syntax





CBP: FSV Entry Role Code or Rejection


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CBP: FSV Entry Role Code or Rejection





CBP: FDA Supplemental Guide for Filers


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CBP: FDA Supplemental Guide for Filers