Short answer: Two obligations, two different parties. Registration with the FDA sits with the producing factory; verifying that your supplier is safe sits with you, the importer. Most processed-food factories also run a HACCP-based food-safety plan. FDA registration is about who is allowed to ship to the US; HACCP is about how the factory controls hazards during production. As the importer, you’re responsible for making sure both are in order — so collect the documentation before you order.
Certifications are where a lot of first-time Asian-food importers get tripped up. This guide explains what FDA and HACCP each cover, who’s on the hook, and exactly which documents to gather.
What FDA registration actually means
One line: It registers the facility with the FDA — it is not a product “approval.”
Facility registration with the FDA, and its renewal cycle, sits with the factory — ask which registrations it holds and when they were last renewed. Important nuances: FDA registration does not mean the FDA inspected or “approved” a specific product — beware suppliers who market “FDA approved,” which for most foods is misleading. Acidified and low-acid canned foods sit under additional FDA process filings, and Prior Notice to the FDA ahead of arrival is part of the import-side paperwork — your customs broker can tell you what applies to your exact product. The FDA can place products on import alert or detain them at the border.
What HACCP actually means
One line: HACCP is a systematic food-safety plan that identifies and controls hazards at critical points.
HACCP (Hazard Analysis and Critical Control Points) is a preventive framework: the factory maps biological, chemical, and physical hazards, sets critical control points (e.g. cooking temperature, pH), and monitors them. For some categories (seafood, juice) HACCP carries regulatory weight beyond good practice, and it is the de-facto expectation for reputable processed-food factories — confirm what applies to your category with your customs broker. Related or overlapping certifications you’ll see include ISO 22000, BRCGS, SQF, and FSSC 22000.
FDA vs. HACCP at a glance
| FDA registration | HACCP | |
|---|---|---|
| What it covers | A facility-level prerequisite for shipping to the US | The factory’s hazard-control system |
| Scope | Regulatory registration | Food-safety management process |
| Product-specific? | No (facility-level) | Plan covers product/process |
| Who can confirm it | No third-party lookup — collect the number from the factory | The certification body that issued the certificate |
| What to collect | FDA registration number, Prior Notice capability | HACCP plan summary, audit certificate, records |
Who is responsible — you are
One line: US food-safety duties sit with the FSVP importer — who may not be the importer of record on your entry — so settle who that is before you ship.
Even if the factory is registered and HACCP-certified, the importer must ensure the product is compliant on arrival: correct English labeling (ingredients, allergen declarations, nutrition facts), no unapproved additives or colorants, and accurate documentation. A single mislabeled allergen can trigger detention or recall.
The documents to collect before you order
- FDA facility registration number — ask the factory for it directly. There is no third-party lookup, and a “certificate” carrying an FDA logo is a red flag rather than proof.
- HACCP plan summary and/or third-party audit certificate (ISO 22000 / BRCGS / SQF)
- Recent lab test reports for the specific SKU (micro, heavy metals, additives as relevant)
- Ingredient and allergen statement for label verification
- Certificate of origin and product specification sheet
How to de-risk your first order
One line: Verify the facility, audit the paperwork, and test the product before committing.
This maps onto tiered factory verification — L1 (legitimacy), L2 (certifications + test reports), L3 (on-site audit). Working with a sourcing partner that verifies factories and collects this documentation for you removes most of the compliance risk from a first-time import.
Key takeaways
- FDA registration sits at the facility level and is not product approval — and not something a third party can confirm for you.
- HACCP = the factory’s hazard-control plan; ISO 22000 / BRCGS / SQF are related audits.
- The importer is legally responsible for compliance and labeling.
- Collect FDA number, HACCP/audit certificate, SKU lab reports, and allergen/label info before ordering.
- Verify to L2+ and test samples to de-risk a first order.
Woklane checks every factory (L1/L2/L3) and helps collect compliance documentation for you. Request a quote to start.
Related reading
- Factory Verification Explained: L1, L2 & L3
- Halal Certification for Importing Asian Food
- Import Compliance: US vs EU vs Southeast Asia
This guide is general orientation, not legal or regulatory advice. Import requirements change and differ by market — always confirm with the competent authority or your customs broker for the destination market before acting.
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