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Compliance

Which Factory Certifications Matter, and Which Tell You Nothing

A certificate answers one question: is this plant audited and under process control. It does not answer whether your product is legal where you sell it. Knowing which certificate covers which question is how you stop being impressed by a PDF that means very little.

6 min read

What a certificate can and cannot tell you

Every factory you contact will send certificates in the first reply. Most buyers scan them for logos and move on, which is roughly the same as verifying a passport by checking it is blue.

A certificate answers exactly one question: has an outside party audited this plant against a written standard, and does the plant still hold that finding. That is worth knowing. It is not the same as any of these:

  • that your formula is legal in your market
  • that your label will clear customs
  • that this plant has ever made your dosage form
  • that the certificate covers the line your product will run on

Those four are where sourcing goes wrong, and no certificate on earth answers them. The obligation for product compliance sits with whoever owns the brand on the bottle — that is not a factory dodging responsibility, it is how the law is written in every market we ship to. What the plant owes you is process control and honest paperwork. What you owe your market is a compliant product.

So read certificates for what they are: evidence about the plant, not permission for your product.

The six we hold, and what each one is for

They do different jobs, and buyers routinely treat them as interchangeable.

Credential What it actually covers
cGMP The manufacturing standard the plant runs to day to day
FDA facility registration US food facility registration, so product may enter the US
GACC export registration Chinese customs filing required before goods leave China
ISO 22000 Food safety management system
HACCP The hazard analysis that sits underneath it
Halal For buyers selling into Muslim markets

Two of these deserve a longer note, because they are the two most often misread in both directions.

FDA registration is a registration, not an approval

This is the single most misrepresented line in supplement sourcing. US food facility registration means the facility has filed with the FDA and may ship food products into the United States. It is a filing. The FDA does not inspect your formula, does not review your label, and does not endorse anything.

Any factory that tells you its products are "FDA approved" is either misinformed or hoping you are. Dietary supplements are not FDA-approved as a category — that pathway does not exist for them. If a supplier's own marketing gets this wrong, treat it as a data point about everything else they tell you.

What registration does give you is a verifiable fact. Registrations are filed, they have numbers, and you can ask for the number for your audit file.

ISO 22000 and HACCP are the two your auditor reads

If your buyer, retailer or 3PL sends an audit questionnaire, these are the two that generate follow-up questions. cGMP is the daily standard, but ISO 22000 is the management system wrapped around it — documented procedures, defined responsibilities, corrective action when something goes out of spec — and HACCP is the analysis identifying where in the process something can go wrong and what control stops it.

Retailers care about these because they describe whether problems get caught, not just whether the plant is clean on the day of the visit.

The signals that tell you nothing

Some things arrive looking like credentials and are not.

A certificate image with no number, scope or issuing body. A cropped JPEG of a wall plaque is not verifiable. Real certificates name the issuing body, carry a certificate number, state a scope, and expire on a date.

"GMP certified" with no standard named. GMP is a family of standards, not one. Ask which standard and which body. A vague answer usually means a self-declaration.

ISO 9001 presented as a food safety certificate. ISO 9001 is a general quality management standard. It applies to a bicycle plant equally well. It is not a food safety certification and does not substitute for ISO 22000.

A certificate whose scope does not include your dosage form. This is the one that costs money. A plant can hold a genuine, current certificate whose scope covers capsules and powders while your product is a gummy. The certificate is real. It just does not cover what you are buying.

A certificate issued to a trading company. If the name on the certificate is not the name of the plant making your goods, you are looking at someone else's audit. Ask whether the entity quoting you is the manufacturer — the answer changes what the paperwork means. Our own position on that is on the about page.

Four checks worth running

These take one email and settle most of it.

  1. Ask for full copies with certificate numbers, not screenshots. A supplier who cannot produce them for your audit file has told you something.
  2. Check that the scope covers your dosage form. Read the scope line, not the logo.
  3. Check the expiry date. Certifications lapse and get renewed; a certificate that expired last year is a question, not a disqualifier.
  4. Verify the FDA registration independently. It is a public filing. You do not have to take anyone's word for it.

What to ask about instead

Once certificates check out, they stop being interesting, because they describe a baseline every serious plant clears. The questions that separate suppliers are about your specific project:

  • Which line will my product run on, and what else runs on it?
  • What testing comes with each batch, and which of it is third-party?
  • Can batch numbers be traced back to raw material lots?
  • What documentation will you prepare for my destination market?

The second of those is the one most worth learning to check yourself, because the answer arrives as a document with every batch you receive rather than as a claim made once during sourcing. We wrote a separate walkthrough on how to read a COA and what else to ask for, including where a specification range can be met on paper and still be wrong for your label.

Those answers vary far more between factories than certificate lists do. We cover what ships with each batch in the FAQ, and if you tell us your destination market and dosage form at the briefing stage we will tell you what documentation exists and what does not — including where you will need your own regulatory advice, because there are questions a manufacturer should not be answering for you.

If you are at the stage of comparing suppliers, send us the market you are selling into and the format you want. You can reach us from the contact page, and the range we can actually produce is on the products page.

Frequently asked questions

Is your factory FDA approved?

No factory is, and neither is any dietary supplement — that approval pathway does not exist for supplements. What we hold is US FDA food facility registration, which is a filing that allows product to enter the United States. It is not an FDA review or endorsement of any formula or label. We can provide the registration details for your audit file.

Which certifications should I ask a supplement manufacturer for?

cGMP for the daily manufacturing standard, ISO 22000 and HACCP for the food safety management system your auditor will read, and the export registration required in the country of manufacture. Add Halal or Kosher only if your market needs it. Then check that each certificate's scope actually covers your dosage form.

Does a factory certification make my product compliant in my market?

No. Certifications describe the plant: audited, under process control, cleared to export. Whether your product is legal where you sell it depends on your formula, your claims and your label, and that obligation sits with the brand owner. We flag problems we can see at the briefing stage, but you need your own regulatory advice for your destination market.

How do I know a certificate a supplier sent me is real?

Ask for the full document rather than a screenshot, and check four things: the issuing body, the certificate number, the scope, and the expiry date. The scope matters most — a current, genuine certificate can easily cover capsules while your product is a gummy. Registrations that are public filings can be checked independently.

Is ISO 9001 enough for a supplement factory?

No. ISO 9001 is a general quality management standard that applies to any industry and says nothing specific about food safety. For supplements you want ISO 22000 and HACCP, which cover food safety management and hazard analysis. A supplier offering ISO 9001 in place of them has not answered the question you asked.

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