Overview: As your company’s properly designated and qualified FDA FSVP Agent and FSVP Importer, United Safety Agents’, (USA), FDA-mandated responsibility is to verify that the physical, chemical, and biological hazards associated with all of your company’s imported products have been – or will be – appropriately controlled prior to public consumption. Your company’s Letter of Consent contains an exhaustive list of products for which USA has agreed to act as the FSVP Agent. The Letter of Consent, and the information that it contains, should only be provided when filing entry with U.S. Customs and Border Protection (CBP) during the importation of previously verified and approved products. If your company would like to import products that are not listed on your Letter of Consent, please notify USA immediately so that we may perform all required actions and ensure that any new products satisfy all FDA standards.

Reporting of Entries:* To safeguard against fraudulent entries and maintain an accurate account of USA’s Data Universal Numbering System (DUNS) number usage, we respectfully request that you submit record of all entries made under FSVP Agency. Please visit USA’s Register of Entries Portal located at unitedsafetyagents.com/shipmentregister and provide:

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1. Date of Entry*

2. Entry/Line number

3. Name of the entered Product and its respective Supplier* and

4. any other data that you believe to be applicable.

You may submit this information either at the time of each entry or in bulk prior to the fifth day before the end of each month. In the event your company has not filed any entries within a given month, no action shall be necessary.   (see “fig. I”)

When a product under FDA oversight is offered for entry into the United States, the U.S. CBP’s Automated Commercial Environment (ACE system) will prompt the filer to transmit a code. When prompted, enter “ FSV ” as the Entity Role Code. 

CODE   |

FSV

DATA ELEMENT  |

Entity Role

Code

CONDITION

IF GOVT Agency program code is FOO and processing code is NSF, PRO, ADD, DSU, FEE, THEN the following FSVP-related details will be mandatory for all FDA FOO lines unless Industry Codes 16 or 32 are present in PG02: 

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1. DUNS#, Firm Name, Firm Address 1 are required in PG19; 

2. All the elements, except Apt#, are required in PG20 AND 

3. Qualifier Code = FSV and eMail address are required in PG21; individual’s name and tel# are optional in PG21. 

If line item is a food and the above items are not transmitted as above, the entry will be rejected by CBP.

Source: FDA Guidance for ACE/ITDA. Version 2.5.1. April 10, 2018. Pg 162

Download the full FDA FSVP Compliance Manual here.

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