Structured record compilation
Supplier records organized into a file a reviewer can follow, with each hazard analysis and its supporting evidence listed.
- Supplier verification file
- Hazard analysis
- Corrective action log
Illustrative example
Food safety · FSVP documentation
FSVP and food safety compliance support, documented clearly.
Clearance Consulting provides structured FSVP program development and written U.S. FSVP representative arrangements under 21 CFR 1 Subpart L, subject to eligibility review and signed consent.
Choose your pathway.
Pathway A: For U.S. importers & consignees
For domestic companies that own the product at port entry and need structured documentation support to build and maintain compliant verification records.
Key services
- FSVP manual builds
- Hazard analyses
- Foreign supplier scorecards
- Form 483 response organization
Pathway B: For foreign manufacturers & exporters
For food subject to FSVP, where no U.S. owner or consignee exists at entry, a U.S. agent or representative of the foreign owner or consignee must serve as the FSVP importer. Clearance considers these engagements only after an applicability review, a written engagement agreement and Clearance’s signed consent to serve as the FSVP importer.
Key services
- Written FSVP representative arrangements (subject to review and signed consent)
- Product and foreign supplier verification record organization
- Documentation support for FDA records requests
- Europe
- Asia
- Latin America
Structured Record ReviewU.S. port of entryScoped annual retainer + technical onboarding (fee set after preliminary technical review).
FDA records request support
Facing an FDA port detention or Form 483?
If you receive an FDA records request, inspectional observations or a Notice of FDA Action, share the complete communication, its issue and receipt dates and any stated response or testimony date. We will assess the requested work, applicable timing and our availability before accepting an engagement.
What the documentation work looks like.
Structured triage
Structured triage of an FDA Form 483 or detention notice: what was cited, which records answer it, and what to send.
- Notice received
- Triage and scope
- Response drafted
Form 483
How representation works
Four stages before any appointment.
Representation starts with a technical review, not a signature.
Stage 1
Technical review
Preliminary review of your facility food safety plans, HACCP controls and compliance history.
Stage 2
Program build
FSVP program and hazard analysis prepared for your products and foreign suppliers.
Stage 3
Written consent
Clearance accepts an FSVP importer designation only after both parties agree to the written engagement and Clearance signs a statement consenting to serve as the FSVP importer under 21 CFR 1.500. An inquiry or use of Clearance’s name does not constitute acceptance.
Stage 4
Ongoing record maintenance
Records kept organized, with response documentation prepared for FDA requests and notices as agreed in scope.
Before the next shipment. Before the next FDA request.
Clearance helps turn scattered supplier information into a documented compliance workflow.
Supplier review
Scenario: an illustrative U.S.-importer record review, not a real product assessment.
Information available
- Product description In file
- Foreign supplier name and address In file
- Supplier food safety documents In file
Information recorded as received.
Evidence to review
- Hazard analysis for the product To review
- Supplier verification records To review
Records identified for review.
Next action
- Request the supplier’s current verification records Open Responsible: Importer
A documented next step and assigned responsibility.
“In file” means the record is available, not that it has been verified, found adequate or approved.
Clear scope. Clear responsibility.
Before work begins, agree the deliverables, required inputs, responsibilities and timing. Keep open questions visible throughout the engagement.
FDA determines inspection findings and admissibility under the laws it administers. Clearance does not guarantee a particular inspection outcome, FDA approval or shipment release. Services are limited to the agreed written scope.
Start with the record you have.
Tell Clearance about your products, your role in the supply chain and the support you need. Include any relevant deadline. Clearance will review the inquiry and confirm whether the request fits the support available.
Scope note
Sending an inquiry does not establish an engagement or confirm that Clearance has accepted responsibility for a deadline.