FOR ASIA-PACIFIC FOOD & COSMETICS EXPORTERS

Will Your Product Survive

U.S. FDA Inspection?

⚠️ 12,000+ Asian food shipments detained at U.S. ports in 2024 — avg. loss $15,000–$80,000 per shipment

Non-compliance = detention, destruction, public Warning Letters. AI 4-layer independent review catches every issue before you ship. 10x faster, 90% cheaper than consultants.

0
Independent Layers
Cross-validated by role
0+
Regulations Checked
CFR · Warning Letters · Alerts
0%
Cost Savings
vs. consultants $2K-10K each
<0h
To Report
Consultants need 2-4 weeks
How it works

Four-Layer AI Review System

Each layer operates independently with a different perspective.

LAYER 01

Initial Screening

Compliance Screener
  • Product classification & RACC
  • Ingredient translation (CN → EN)
  • 9 major allergen check
  • Nutrition Facts conversion
  • Claims verification
LAYER 02

Senior Review

Senior Regulatory Reviewer
  • Independent recalculation
  • GRAS/FDA status verification
  • Data consistency check
  • Warning Letter pattern matching
  • Triggers GRAS/NDI research
LAYER 03

Customs Screening

CBP Import Officer
  • Import Alert risk assessment
  • Prior Notice requirements
  • LACF / FSVP evaluation
  • Entry document checklist
  • Detention risk estimation
LAYER 04

FDA Review

CFSAN Food Safety Reviewer
  • Final compliance determination
  • Simulated FDA inspection
  • Corrected Nutrition Facts
  • Warning Letter risk prediction
  • GRAS/NDI recommendation

Deliverables

What You Get

🛡️

Compliance Report

Detailed PDF report with all 4 layers, CFR citations, and corrective actions.

📋

Corrected Label

FDA-format Nutrition Facts panel and complete English label mockup.

🧬

GRAS/NDI Reports

Auto PubMed literature search and draft GRAS/NDI notifications.

🔍

Allergen Audit

Cross-check 9 allergens including hidden sources in compound ingredients.

🌏

Taiwan → USA

Auto-convert Taiwan labels to FDA format with RACC and rounding.

💰

Cost Savings

Traditional: $2K-$10K per review. Get comparable analysis at a fraction.

MoCRA 2022 + FDA 21 CFR

Cosmetic Compliance Review

5-layer independent AI review covering all MoCRA provisions. From ingredient screening to safety substantiation, labeling to import risk.

L1Regulatory Screener

Classification, prohibited ingredients, color additives, INCI

L2MoCRA Compliance

Labeling, facility registration, product listing, SAE

L3Safety Science

Toxicology, CIR/SCCS, stability, PET, clinical data

L4CBP Import

Import Alerts, U.S. Agent, detention risk scoring

L5FDA Final

Final determination, corrected label, Warning Letter risk

🧪

Ingredient Safety

Prohibited/restricted ingredients, CIR safety, Prop 65, PFAS screening

🏷️

Label Compliance

INCI verification, MoCRA contact info, warnings, dual units, English labeling

🔬

Safety Substantiation

MoCRA §608 safety assessment, stability, PET, microbial limits, clinical data gaps

🏭

Facility Compliance

FDA registration, product listing, GMP/ISO 22716, small business exemption

🚢

Import Risk

Import Alert check, U.S. Agent, Responsible Person, detention risk quantification

⚖️

Drug/Cosmetic Classification

Auto-detect drug claims, SPF/antiperspirant/acne → OTC Drug, dual compliance path

Ready to enter the U.S. market?

Upload your product data and get a comprehensive review in hours.