Regulatory Support

You stay the importer. We do the qualified individual’s work.

Foreign supplier verification is not a filing you complete once. It is a program that has to stay true as your suppliers, products and shipments change. We provide the qualified individual and keep the program current, month after month, for however many suppliers you carry.

All Regulatory Support subscriptions

What this is

The part of importing that nobody is staffed for.

A qualified individual can perform the verification activities, and does not have to be your employee. What that changes is who does the work, not whose program it is — you are the one bringing the food in, and the program stays yours. What it does mean is that the reading, the evaluating, the hazard analysis and the recordkeeping can sit with somebody who does this every day, instead of with whoever in your company has the least on their plate.

The work does not stop. A new product, a new supplier, a changed process, a certificate that expired — each one moves the program, and a program that has drifted looks identical to one that has not until somebody asks to see it.

Foreign Supplier Verification

We provide your qualified individual and run the program — the evaluations, the hazard analyses, the verification activities — kept current as your supply chain changes.

The division

We do

Perform and document the qualified individual activities, each signed by the individual who performed them
Evaluate each foreign supplier and keep that evaluation current as things change
Build and maintain the hazard analysis for each type of food you import
Determine and run the appropriate verification activity for each one
Keep the records in English and in a state you can produce them from when FDA asks
Tell you when a document you send us does not match what the program says you are buying

You keep

The importer role. We never act as the FSVP importer and never appear as importer at entry
Your own name, email address and facility identifier on each entry line
The decision to buy, to accept a shipment, and to keep or drop a supplier
Responsibility for telling us what changed — a new product, a new source, a new certificate
We do not act as a foreign supplier’s US agent, and we do not guarantee any shipment is admitted. Neither of those is verification work, and neither belongs in the same arrangement

What comes back

A maintained program rather than a folder. Every determination states what it rested on and the date it was made, so a records request is answered from a file that is already true instead of assembled in a panic.

When it turns out to be bigger

You send us the request and we answer it from the work we have done for you, inside the subscription. If the request turns into something larger — a response to findings, an inspection that goes somewhere, a program rebuilt from scratch after a supplier turns out not to be who the paperwork says — we tell you before starting and quote it.

What this catches

Three programs that read as complete and are not.

Constructed examples. The companies are invented; the failure modes are ones that turn up in real import files.

The supplier on every document does not manufacture anything.

Reads asOne named foreign supplier, a certificate on file, and a hazard analysis for every product traced back to it. Tidy, consistent, complete.

Hiding in itThe company on the paperwork does supply chain management, quality control and logistics. Its own quality certificate covers the sale and purchase of goods, not their manufacture. The plants that actually make the food are somewhere behind it and are named nowhere.

Why it mattersThe rule defines the foreign supplier as the establishment that manufactures or processes the food, raises the animal, or grows it, where that food is exported to the United States without further manufacturing or processing by another establishment, setting aside labeling and anything similarly minor. Name a trading company instead and every supplier evaluation in the file is built against the wrong company’s performance history, which nobody notices until FDA asks who made it.

21 CFR 1.500 — definition of foreign supplier

Identity was confirmed on something other than what arrived.

Reads asA certificate of analysis from the supplier’s laboratory. Identity confirmed, every result within specification, signed.

Hiding in itThe identity test was run against the raw botanical. What shipped is an extract, and the method named on the certificate cannot separate it from the cheaper things extracts of that plant are commonly cut with.

Why it mattersA verification activity has to actually verify the hazard it was chosen for. A certificate whose method does not reach the question is a document in the file, not a control.

The certificate is real, current, and about the wrong thing.

Reads asAn audit certificate from a recognized body, in date, covering the supplier’s site.

Hiding in itIts scope is a management system rather than food safety, or it covers a different site, or it was first issued three months ago for a supplier described as long established.

Why it mattersVerification rests on what the certificate actually attests to. Reading only the logo and the expiry date is how a file passes internal review for years and fails the first time somebody reads the scope line.

Setup, priced once by the size of what has to be established

Up to 5 suppliers

$3,500

One-time

6 to 20 suppliers

$6,500

One-time

Over 20 suppliers

$10,000

One-time

Tap the band that matches you. It sets how many we establish at the start — a smaller band costs less and takes longer to work through.

After setup the monthly fee does not move, however many suppliers or products you add. This work is normally priced per supplier and per code — which means the day you add a supplier you are doing arithmetic instead of verification.

Due today$3,500Setup for up to 5 suppliers · then $2,000 per month
Any number of suppliers and products · billed monthly in advance and renews automatically each month until you cancel
Cancel any time before your next renewal · no refund for an unused month

Common questions

Straight answers.

Can you be our FSVP importer?

No. FDA lets you use a qualified individual to perform the activities; it does not let another company take on your responsibility for having a program and following it. We do the work and you remain the importer, which is the only arrangement that survives an inspection.

What happens when we add a supplier?

You tell us and we run it — evaluation, hazard analysis for each food, the verification activity and the records. The monthly fee does not change. That is the point of it not being metered.

We already have a program. Do we start over?

Usually not. Setup reads what you already hold and tells you what is sound, what is thin, and what is pointed at the wrong entity. Where the bones are good we keep them. Where they are not, you find out before an investigator does.

FDA has asked us for records. Can you help?

That is what the program exists for. You send us the request, we answer it from the work we have done for you, and that is inside the subscription. If the request turns into something larger — a response to findings, an inspection that goes somewhere — we tell you before starting and quote it.

Does every importer need the full program?

No, and it is worth finding out early. The rule carries modified paths — dietary supplements and their components, very small importers, and food from countries with a recognized food safety system each follow a shorter route, and a receiving facility already meeting the preventive controls rules is treated differently again. Setup establishes which one you are actually on, because building the full program when you are on a modified path is expensive and building the short one when you are not is worse.

Who talks to our suppliers?

You do, or you introduce us and we do it in writing with you copied. What we will not do is chase a supplier indefinitely on your behalf. Where a supplier will not produce what verification requires, that is a finding about the supplier, and it is yours to act on.

Is this legal advice?

No. It is regulatory work product. It does not guarantee admission of any shipment or any outcome with FDA, and where something looks to us like a question for a lawyer, we say so.

The rest of the pillar

Plenty of importers hold more than one.

Regulatory work product, not legal advice. Regulatory Options performs qualified individual activities on behalf of the FSVP importer. It does not act as the FSVP importer, does not appear as importer of record or FSVP importer at entry, does not serve as a foreign supplier’s US agent, and does not guarantee that any shipment will be admitted. The importer remains responsible for having and following a foreign supplier verification program, and for its own compliance, decisions, entries and submissions. What this subscription covers is set out above. Work outside it — rebuilding a program after a supplier turns out not to be who the paperwork said, responding to findings, or an inspection that goes somewhere — is named as such and quoted before anything starts, and never begun without your agreement. Every determination states what it rested on and on what date, and holds only while those facts remain accurate; we are responsible only for information actually submitted to us through the channel we designate. Records are maintained from what you and your suppliers provide and are not independently verified. Companies and situations shown as examples are constructed; no real company is depicted. Billed monthly in advance and renews until canceled, with no refund for an unused month, and setup is charged once at signup, under our Terms of Service and Privacy Policy.