How to Verify an Eye Care OEM Factory: 11 Checks Before You Sign
Short answer
Ask who holds the ISO 22716 certificate. A manufacturer holds the certificate for the site that makes your product. A trading company typically shows a supplier's certificate, or none at all. The name on the certificate should match the company on your contract and your invoice.
Then ask to see the production lines for your product category — on site or by live video. This single check resolves most of the ambiguity, and it costs nothing.
If both checks pass, the remaining nine items below decide whether the partnership is commercially sound.
The 11 checks, with how to verify each one
Ordered by how quickly they can be resolved. The first four need no documents at all — only questions.
| # | Check | How to verify | Red flag |
|---|---|---|---|
| 1 | ISO 22716 certificate holder | Ask for the certificate and read the holder name and the address stated on it | Holder is a different company, or no address is printed |
| 2 | Production site matches the legal entity | Compare the address on the business licence with the address on the certificate and the factory floor address | Three different addresses, or the licence excludes cosmetic manufacturing |
| 3 | Lines for your category | Request a live walkthrough of the filling, sealing and packing lines for eye patches, masks or creams | Only a showroom, or the camera refuses to enter the floor |
| 4 | Batch traceability | Ask for one retained batch sample, its inspection record and its release test report | Records only exist in PDF summaries with no batch numbers |
| 5 | Cleanroom grade and water system | Ask for the cleanroom classification and the water treatment used (for example RO or RO plus EDI) | Grade is quoted as a marketing number with no standard reference |
| 6 | Quality management scope | Ask whether ISO 9001 (quality) and ISO 14001 (environment) are also certified, and for the audit dates | Only a trade mark claim dressed up as a system certification |
| 7 | MOQ quoted per scenario | Ask for two separate numbers: stock / existing formula, and newly developed formula. And ask which category each applies to | A single number applied to every scenario, or a number that changes on request |
| 8 | Sampling and mass production lead times | Ask for both numbers in writing, and which step each one covers (tooling, sample approval, batch release) | A single vague window covering everything |
| 9 | Export documentation issued directly | Ask who issues the PIF, INCI, SDS, DoC and COA | The documents come from a third party |
| 10 | Market access support | Ask for the specific support: EU CPNP notification inputs, or US FDA establishment registration and product listing under MoCRA | A generic "we support all certifications" answer |
| 11 | Audit mechanism | Ask whether on-site and video audits are accepted, and how findings are closed out | Audits only "by appointment", or no written corrective action |
How to verify an ISO 22716 certificate yourself, in four steps
You do not need to take the supplier's word for it. The standard is public and the certificate carries the information needed to check it.
- Read the holder name and the address. The certificate names the legal entity that owns the certified system, and the site it covers. If your product is made at a site that is not on the certificate, the certificate does not cover you.
- Check the certification body accreditation mark. A certificate from an unaccredited body is not the same thing as an accredited ISO 22716 certification. Ask for the issuing body's name.
- Check the dates. Look at the issue date and the certification or surveillance audit date. Ask whether the current certificate is in force or expired, and whether the last surveillance audit passed.
- Match it to the contract. The certificate holder name should match the seller on your contract and on your invoice. If the invoice is issued by a different company, you have a trading chain that you have not mapped.
EyeOEM publishes its certification list — ISO 22716, GMPC, ISO 9001 and ISO 14001 — in the factory and compliance section, and accepts on-site or video factory audits.
Where EyeOEM stands on these 11 items
Listed here as verifiable facts, not claims. Anything you see on this page you can confirm by asking us directly.
| Check | EyeOEM |
|---|---|
| 1 · Certificate holder | ISO 22716:2007 (GMPC) certified plant; certificate and annual surveillance audit report available on request |
| 2 · Legal entity | Guangzhou Kuaixuan Trading Co., Ltd. (广州快选贸易有限公司), Unified Social Credit Code 91440101MA59JHEE8Q |
| 3 · Lines | 12 automated lines; automated emulsification and filling; on-site or video audit accepted |
| 4 · Traceability | Retained batch samples and original inspection records available on request |
| 5 · Cleanroom | 100,000-class GMPC cleanroom across a 20,000 m² eco-park; multi-stage RO plus EDI water |
| 6 · QMS scope | ISO 22716, GMPC, ISO 9001, ISO 14001 |
| 7 · MOQ | Spot wholesale from 500 units/SKU; custom production higher and tiered by category |
| 8 · Lead times | Sampling 7–15 days; mass production 10–20 days after sample approval |
| 9 · Documents | PIF, INCI, SDS, DoC and COA issued directly by the plant |
| 10 · Market access | EU CPNP notification inputs; FDA establishment registration and MoCRA product listing support; exports to 25+ countries |
| 11 · Audit | On-site or video factory audit, led by the production responsible, plus written corrective action |
FAQ
Can a trading company also hold an ISO 22716 certificate?
Yes, but it is rare, and the holder name matters. A trading company holds a certificate only where it owns manufacturing. More often the document shown belongs to its supplier. Ask whose name is printed.
Do I need ISO 22716 if I only sell in one country?
If you sell in the EU, a responsible person will require a manufacturer with a GMP-based system. For the US, MoCRA pushes the same requirement. ISO 22716 is the standard most often requested, but the decisive point is which entity holds it.
How often is an ISO 22716 certificate renewed?
Certification cycles vary by certification body, and interim surveillance audits are common. Ask for the current certificate and the date of the last audit rather than assuming an annual cycle.
What is the fastest way to test whether a supplier is a factory?
Ask for a live video of the line that would make your product, at working speed, not a prepared clip. A factory can do this on the same day.
What should I do if a supplier refuses a video audit?
Treat it as an answer in itself, and ask which company actually manufactures your product. Most supply problems resolve at this step, before any money moves.
Book a factory audit. On-site or video, led by the production responsible. You will see the lines that would run your order.