ONGOING COMPLIANCE
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 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 Importer/Agent.
The Letter, 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 you would like to import products that are not listed on your Letter, kindly notify our firm so that we may perform all required actions and ensure that any new product meets FDA standards.
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Reporting Entries to United Safety Agents: To safeguard against fraudulent entries and maintain an accurate account of USA’s Data Universal Numbering System (DUNS) number usage, we respectfully request that your office submit record of all entries made under FSVP. Please visit USA’s Register of Entries Portal located at unitedsafetyagents.com/shipmentregister
For each entry-line, we ask that you provide:
[A] Date of Entry*
[B] Entry/Entry Line Number
[C] Name of Product and its respective Supplier* and
[D] all other applicable information.
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”)
Filing Entry with U.S. Customs: When an item under FDA oversight is offered for entry into the U.S., the U.S. Customs and Border Protection (CBP) Automated Commercial Environment (ACE) system will prompt the filer to transmit a code: When prompted, enter “FSV” as the Entity Role Code. This code will send a signal to the ACE system indicating the entry line is subject to FSVP and will trigger a request for the FSVP Importer’s name, email address, and DUNS number as the UFI recognized as acceptable by FDA. See https://www.unitedsafetyagents.com/filing for all CBP Filing Guidance.
for use by FSVP Importer/Agent clients only.
PG19
080801169 (Unique Facility Identifier)
080801169
080801169
United Safety Agents LLC
715 West Park Avenue
DUNS Number
Entity Identifier Code
Entity Number
FSVP Importer Name
Entity Address 1
PG20
222
Oakhurst
New Jersey
United States (USA)
07755
Entity Address 2
Entity City
Entity State
Entity Country
Entity Zip
PG21
Individual Qualifier
Individual Name
Telephone
Email Address
Other
Establishment ID
Tax ID Number
3014302990 (FEI Number)
822349285
Note: See Letter of Consent for additional information
Important: If line item is a food, beverage, or supplement and the above codes are not transmitted, the entry may be rejected.
"UNK" is no longer acceptable, if used the entry may be rejected by CBP.
Requirement for Up-To-Date Documents: 21 CFR part 1, subpart L requires that all FSVP records be updated and maintained. USA ensures that there will not be an FSVP-related issue during the entry process by continually monitoring each product’s compliance with the relevant regulatory guidelines. We request that your company provide updated food safety documents on an annual basis, or sooner if any changes are made.
Penalties for Non-Compliance: The importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act, including the requirements of this subpart, is prohibited under section 301(zz) of the FD&C Act. As provided by §1.514, FDA can impose a wide range of penalties when firms choose to operate outside of FSVP. FDA has confirmed their intentions to ensure compliance with FSVP.
Import Refusal An article of food is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act if it appears that the importer fails to comply with FSVP.
Import Alert An Import Alert for FSVP noncompliance is applicable to any human/animal food subject to FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). Import Alert 99-41: An importer may be added to the Red List of this import alert because it appears that the importer is not in compliance with FSVP requirements for one or more foods.
Red List The specific food or foods from a specific foreign supplier may be included on the Red List to identify the food or foods that are subject to DWPE when imported or offered for import by the identified importer. In some cases, an importer may be subject to DWPE for all food that the importer imports if it appears that the importer is in violation of FSVP requirements for all such foods.
DO NOT import a food item bound under FSVP if: 01) the item has not successfully undergone FSVP verification and is currently approved for importation, or 02) your company’s FSVP compliance coverage has expired.
Questions? We are here to help.
Download the full FDA FSVP Compliance Manual here.
