Short answer: When you import Asian food into the US, the producing facility must be registered with the FDA, and most processed-food factories should operate 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.”
Facilities that manufacture, process, pack, or hold food for US consumption must register with the FDA and renew biennially. 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. Certain products (acidified/low-acid canned foods) require additional FDA process filings, and shipments typically require Prior Notice to the FDA before arrival. 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. HACCP is legally required for some categories (seafood, juice) and is the de-facto expectation for reputable processed-food factories. 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 | The facility’s permission to ship 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 verifies | FDA (self-registration + oversight) | Factory + third-party audits |
| What to collect | FDA registration number, Prior Notice capability | HACCP plan summary, audit certificate, records |
Who is responsible — you are
One line: The importer of record carries legal responsibility for compliance and labeling.
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 (and confirmation it’s current)
- 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 = facility permission to ship; it is not product approval.
- 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 verifies every factory (L1/L2/L3) and collects compliance documentation for you. Request a quote to start.
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