The Importer's Shield.
Complete Foreign Supplier Verification Program (FSVP) solution. We provide the Qualified Individual, Hazard Analysis, and Recordkeeping required by FDA.
You need a Qualified Individual.
FDA rules (21 CFR 1.503) state that FSVP activities must be performed by a “Qualified Individual” with specific education and experience. If you don't have a food scientist on staff, you are non-compliant.
Hazard Analysis
Engine.
You must evaluate every known or reasonably foreseeable hazard for each food you import. Our engine checks against FDA's database of biological, chemical, and physical risks automatically.
The Verification Loop.
FSVP isn't a one-time form. It's an ongoing cycle of verification. We automate the annual reviews, supplier audits, and document checks so you never fall behind.
危害分析与关键控制点
Records must be in English.
Your foreign supplier sends you safety plans in Chinese, Spanish, or Italian? FDA requires English. Our platform includes automated, certified-grade translation for compliance records.
Audit Defense
Mode.
When FDA issues a Form 482 Notice of Inspection, you have hours to respond. Our Audit Defense Hub organizes all your records instantly, so you can hand over a perfect package.
- 24/7 Response Team
- Mock Audits
- Record Retrieval
Remote Regulatory
Assessments (RRA).
FDA doesn't need to visit your office to audit you anymore. RRAs are virtual inspections conducted via video and document upload. Our platform is built to ace the RRA interface.
Map your
Compliance Chain.
Visualize every supplier, manufacturer, and grower in your network. See instantly who is compliant, who has an expiring certificate, and who is blocked.
Fix it before
it fails.
If a supplier fails verification, you must document a Corrective Action (CAPA). Our workflow guides you through the root cause analysis and resolution required by 21 CFR 1.508.
The 2-Year
Vault.
You must keep FSVP records for at least 2 years after the record was created or obtained. Our secure digital vault handles retention automatically, ensuring you never lose a file.
Special Rules for Supplements
Dietary Supplement importers have modified FSVP requirements under 21 CFR 1.511. We handle the difference.
Modified FSVP
If you verify GMPs under Part 111, you don't need a full standard FSVP.
Finished Products
Different rules apply for finished supplements vs raw dietary ingredients.
Serious Adverse Events
Mandatory reporting connection for supplement importers.
Platform vs. Consultants.
Traditional consultants charge thousands per FSVP plan. We use technology to deliver better compliance at a fraction of the cost.
Don't risk a 483 citation.
Start your FSVP program today with a Qualified Individual ready to go.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.