# ISO 22716 & US FDA GMP Quality Control | Yanmei Bio-Tech

- **Canonical URL**: https://yanmeicos.com/quality//
- **Entity**: Guangzhou Yanmei Biotechnology Co., Ltd. (YANMEI COS)
- **Direct Engineering Contact**: Alex Gao (alex@yanmeicos.com)

Home / QUALITY ASSURANCE · CLEANROOM QC · GROUP CERTIFICATIONS


# Quality Assurance, Cleanroom QC & Verified Group GMP Credentials

Yanmei Bio-Technology (Guangzhou Yanmei Biotechnology Co., Ltd. · YANMEI COS) operates dedicated single-dose personal care filling lines backed by verifiable parent-company certifications (Fujian Yanse Cosmetics Co., Ltd.) and strict batch-level analytical release.


## Verified Group Certifications & Regulatory Scope Disclosure

| Engineering / Compliance Dimension | Verified Yanmei Bio-Tech Standard |
| ISO 22716:2007 Cosmetics GMP | CNSH25778319-ISO22716 (Bureau Veritas) — held by parent company Fujian Yanse Cosmetics Co., Ltd. |
| US FDA Cosmetic GMP Guidance | CNSH25778319-USFDA (Bureau Veritas) — held by parent company Fujian Yanse Cosmetics Co., Ltd.; supports US MoCRA alignment |
| Social & Ethical Audits | amfori BSCI & Sedex 4P (SMETA 4-Pillar) — held by parent company Fujian Yanse Cosmetics Co., Ltd. |
| China Production Licence & FSC | 闽妆20250005 (NMPA Fujian), Free Sale Certificate 2025YB2129, FSC Chain of Custody & Halal (parent company scope) |
| Micro-Dose Fill Precision | ±0.1 g gravimetric inline checkweighing across 0.35 ml capsules, 4.5 g eye patches, and 10–15 ml mouthwash pods |
| Seal & Barrier Integrity | -0.08 MPa vacuum chamber dye-penetration leak test (30 min, zero seepage) + 45°C / 75% RH 90-day accelerated stability |
| Microbial & Export Dossiers | USP <51> / ISO 11930 preservative efficacy, heavy metals, COA, 16-section SDS, EU CPNP PIF & EAEU TR CU 009/2011 support |
| IP & Formula Protection | 100% private-label only (zero competing consumer brand) under legally binding NNN agreements |

## Frequently Asked Buyer Questions


### Who holds the ISO 22716 and US FDA GMP certificates?

Our parent company, Fujian Yanse Cosmetics Co., Ltd., holds Bureau Veritas ISO 22716 (CNSH25778319-ISO22716) and US FDA Cosmetic GMP (CNSH25778319-USFDA) certificates. Yanmei Bio-Technology is its dedicated subsidiary for single-dose personal care OEM/ODM.


### What quality tests are run on every mouthwash pod and skincare batch?

Every production lot undergoes pH, viscosity, refractive index, ±0.1g fill-weight verification, -0.08 MPa vacuum seal integrity testing, total aerobic microbial count (<100 CFU/g for eye/oral zones), and retention sample archiving.


### Can retail buyers request audit reports and COA/SDS before bulk PO?

Yes. Contact Alex Gao (alex@yanmeicos.com) with your target market and SKU format to receive full redacted BV audit summaries, COA, SDS, and 7-day lab samples.


## Request Free 7-Day Lab Samples & Tiered FOB Quote

Direct engineering desk led by Alex Gao ( alex@yanmeicos.com ). Pilot runs from 5,000–10,000 units with full US MoCRA, EU CPNP & EAEU dossiers.