Audited & Verified
Certifications & Compliance
Five certification tracks apply to our manufacturing operation — not a trading office. Below is what each one covers, which site it applies to, and which documents we release to brand partners, retailers and their auditors on request.
At a Glance
Certifications & Audits Across Our Manufacturing Operation
The certifications most often requested by US, EU, UK and Middle East buyers before they place a first order.
What FDA registration does and does not mean. Registration applies to a facility, not to a product: the FDA does not register, approve or certify individual dietary supplement products, formulas or labels. Our FDA registration confirms that the Guangzhou facility is on the FDA food facility register and that we file Prior Notice for US-bound shipments; how the product is made is governed by cGMP under 21 CFR part 111.
Certification Register
What Each Certificate Covers
Scope, subject area and the evidence we release — so you can match our documentation to your own compliance requirements.
| Certification | Full Name / Standard | What It Covers | Evidence Released on Request |
|---|---|---|---|
| FDA-Registered Facility | U.S. Food & Drug Administration — food facility registration | Registration of the Guangzhou facility that manufactures, processes and packs dietary supplements for the US market, renewed biennially under section 415 of the FD&C Act. Registration applies to a facility, not to a product or a formula. | Registration confirmation, FEI number and FDA Prior Notice filing records |
| GMP / cGMP | Current Good Manufacturing Practice (21 CFR Part 111) | Production, packaging, labelling and holding of dietary supplements — enforced across every line, every shift, every batch. | Batch manufacturing records and internal audit reports |
| ISO 22000 | Food Safety Management System | Whole-facility food safety management, from raw material intake and supplier qualification through to dispatch and traceability. | Certificate of registration and surveillance audit reports |
| HACCP | Hazard Analysis and Critical Control Points | Documented critical control points for microbiological, physical and chemical hazards across all seven dosage forms. | HACCP plan, CCP monitoring logs and verification records |
| BRCGS | Brand Reputation Compliance Global Standard (Food Safety Issue 9) | Retailer-mandated global food safety standard covering senior management commitment, HACCP, site standards and product control. Audited site: our group's Wuxi (Jiangsu) facility, grade A. | BRCGS certificate and audit report, stating audit scope and site |
Third-Party Testing
Documentation Behind Every Batch
Certificates prove the system. Batch documentation proves the product in your carton.
Certificate of Analysis (COA)
Every batch ships with a COA recording ingredient identity, assay, microbiological results and heavy-metal results against the agreed specification.
Ingredient Identity Testing
Incoming raw materials are sampled and identified before release to production — suppliers must be qualified and provide their own specification and COA.
Microbiological Screening
Total plate count, yeast and mould, E. coli and Salmonella are screened as standard, with additional organisms tested for products targeting children or immune-support claims.
Heavy-Metal Testing
Lead, mercury, arsenic and cadmium are tested against the limits of your destination market — US, EU, UK, Canada, Australia and the GCC requirements can all be accommodated.
Stability & Shelf-Life
Accelerated and real-time stability studies support the shelf life printed on your label, covering potency loss, appearance and microbial integrity over time.
Retained Samples & Traceability
Batch samples are retained for the shelf life of the product, and raw material lot numbers are traceable from finished goods back to supplier in both directions.
Due Diligence
How to Verify Us Before You Order
Three steps any serious buyer should take — we expect them, and we make them easy.
Ask for the document pack
Tell your account manager which markets you sell into. We release the certificate set, audit reports and batch COA templates relevant to those markets, under NDA.
Check our registration numbers
Every registration and certificate carries a number you or your auditor can verify directly with the issuing body — our FDA food facility registration and FEI number, ISO 22000, HACCP, BRCGS and the third-party GMP verification report.
Audit us on site or remotely
Brand owners and their third-party auditors are welcome at the Guangzhou plant. If travel is not practical, we run a live video walkthrough of the relevant lines and stores.
Frequently Asked
Certification & Compliance FAQ
What buyers ask our regulatory team most often about certificates, testing and claims.
Which certifications does Yukang Medicine hold as a supplement manufacturer?
Our Guangzhou plant is registered with the FDA as a food facility and runs to cGMP (21 CFR Part 111), supported by ISO 22000 food safety management and HACCP systems; our group also operates a BRCGS-audited site in Wuxi, Jiangsu. FDA facility registration is not an approval or certification of any product — the FDA does not register or approve individual dietary supplement products or formulas. Certificate numbers, issuing bodies, audit sites and current validity dates are released to brand partners, retailers and their auditors on request — tell us which markets you sell into and we will send the document set that applies to them.
Can I see the actual certificates and audit reports before placing an order?
Yes. We release the certificate set, surveillance audit reports and batch Certificate of Analysis templates to brand partners and retailers on request, under NDA. Tell us which markets you sell in and we will send the documents relevant to those markets.
Are your certifications recognised in the United States and the European Union?
Our FDA food facility registration, with Prior Notice filed for each US-bound shipment, supports dietary supplement export to the United States, and cGMP compliance is measured against 21 CFR Part 111. ISO 22000 and HACCP are internationally recognised food safety standards applied in the EU, UK and most other markets, and BRCGS — the standard many European and UK retailers require from their suppliers — is held by our group's Wuxi (Jiangsu) facility; we confirm which site will supply your order before you commit.
Do you provide a Certificate of Analysis with every batch?
Yes. Every production batch is released with a Certificate of Analysis covering ingredient identity, assay, microbiological results and heavy metals against the specification you approved. Retained samples are kept for the shelf life of the product so any batch can be re-tested later.
Can you manufacture certified organic, non-GMO, vegan, kosher or halal products?
Yes. We source certified raw materials and can manufacture organic, non-GMO, vegan and kosher-market dietary supplements, including gelatin-free gummies and vegetarian capsule shells. Where a finished-product claim requires third-party certification — halal, organic or kosher — we work with the relevant certification body and support the audit for your product rather than relying on a blanket certificate of our own, and we reflect the claim correctly on your FDA or EU label.
What happens if a batch fails a quality test?
Failed material never reaches the finished-goods store. Raw material that fails identity or specification is rejected and quarantined; finished product that fails release testing is held and either reworked against an approved deviation or destroyed, with the decision and the record documented for audit.
Request Our Certification & Audit Documentation
Tell us which markets you sell into and we will send the certificate set, audit reports and COA templates relevant to those markets. NDA protected.
Request Documentation