Hazard analysis
A food-specific hazard analysis identifying known or reasonably foreseeable hazards for each food, based on the supplier's documentation and the importer's knowledge — not a generic template.
The most rigorous FSVP file an importer can have.
ImportGuard assembles an audit-ready, FDA-defensible Foreign Supplier Verification Program file for every foreign supplier×food you import — hazard analysis, supplier verification, and maintained records — checked against 21 CFR 1 Subpart L before a qualified individual releases it.
Every subsection of 21 CFR 1 Subpart LHazard analysis & supplier verification, gate-checkedFDA import refusal & warning letter risk screenedQualified individual sign-off on every file5-business-day SLA
Why FSVP files fail
A missing or generic FSVP can stop your shipment at the border.
Every U.S. importer of FDA-regulated food must have an FSVP for each foreign supplier×food combination. FDA inspects and cites: 44.2% of over 1,700 inspections found no FSVP at all. A generic hazard analysis or missing supplier verification is enough for a Form 483, a warning letter, or an import refusal.
Most importers build FSVPs by hand, per supplier, using outdated templates. The regulation is dense, the supplier documentation is messy, and the qualified individual requirement creates a bottleneck. That is exactly where compliance gaps hide.
ImportGuard exists to close that gap with a single, exhaustive standard applied identically to every file.
44.2%
of FSVP inspections cited for having no program at all
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every file is scored against a versioned rule pack tied to the exact text of 21 CFR 1 Subpart L. These are the provisions each file is held to.
Supplier verification activities
Appropriate supplier verification (e.g., onsite audit, sampling, records review) determined based on hazard analysis and supplier performance, with evidence of performance.
Corrective actions
Procedures for corrective actions when supplier verification reveals a problem, including notification and re-evaluation.
Qualified individual review
The FSVP must be reviewed and signed by a qualified individual who has the necessary education, training, or experience.
Records maintenance
All FSVP records maintained for at least 2 years, with the importer's records room organized and inspection-ready.
Reassessment every 3 years
FSVP reassessed at least every 3 years, or sooner when new information arises — tracked on a compliance calendar.
How a file is built
Intake to QI release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A qualified individual signs every release. That order is never reversed.
01
Compliance Gap Scan
Upload your supplier list and entry data. We return a free completeness read: which FSVP elements you already have, and which are missing.
02
Supplier documentation intake
As your authorized clerical agent, we collect and organize supplier food safety documentation (COAs, GFSI certificates, product specs, process descriptions) and entry records.
03
Grounded drafting
The hazard analysis and supplier verification determination are drafted from validated data and the 21 CFR 1 Subpart L rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
Hazard analysis covers all known hazards; supplier verification matches risk level; corrective action procedures are documented; QI credentials are verified. Any failure blocks release.
05
Qualified individual release
A trained QI reviews the exception queue and signs the release. High-risk or high-value files route to a senior QI or attorney review first.
06
Delivery
You receive the file: hazard analysis, supplier verification determination, corrective action plan, records log, and a compliance calendar — ready for FDA inspection.
The bar we hold
Rigor you can measure.
100%
QI-released
No file ships without a qualified individual signature.
5 days
Standard SLA
From complete intake to released file.
<1%
Critical-defect target
Tracked against a gold-standard file library.
4
Document sources
Supplier docs, entry records, FDA databases, and regulatory text — every applicable file.
Why ImportGuard
Built to be the most thorough option an importer has.
Documentation-complete, by design
The deliverable is completeness itself — every regulatory element and document accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run searches as your clerical agent. We never give legal advice, contact FDA on your behalf, or act as your FSVP agent unless explicitly engaged.
Engagement
Flat fee, per supplier×food file, per year. No hourly billing.
Simple, predictable, and aligned with a compliance standard — not a cut of any recovery.
- A free Compliance Gap Scan before you commit — see exactly what is missing.
- One flat onboarding fee per supplier×food file plus recurring annual maintenance; disclosed pass-through costs for third-party audits if needed.
- Optional fixed-fee senior QI or attorney review for high-risk or high-value files.
- Optional Reassessment Continuity Add-on for the 3-year reassessment cycle, pre-dated to your compliance calendar.
FAQ
Questions, answered precisely.
Is ImportGuard a law firm?
No. ImportGuard, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Qualified individual review is available and recommended for all files.
Do you contact FDA or act as my FSVP agent?
No. ImportGuard does not contact FDA or act as your FSVP agent unless explicitly engaged under a separate agency agreement. The importer remains the responsible party for FSVP compliance and for responding to FDA inquiries.
What makes a file 'complete'?
Completeness is defined by the regulation: hazard analysis covering all known hazards, appropriate supplier verification, corrective action procedures, QI sign-off, and records maintenance. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a QI-released file. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat onboarding fee per supplier×food file plus recurring annual maintenance. No hourly billing and no percentage of any recovered amount or sale proceeds.
See what's missing before FDA does.
Start with a free Compliance Gap Scan. Send your supplier list and entry data and we'll return a completeness read against every subsection of 21 CFR 1 Subpart L.
Documentation-completeness service · not legal advice · the importer remains responsible for FSVP compliance.