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ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD

Low Risk

FEI: 3020176146 • WENZHOU • CHINA

FEI

FEI Number

3020176146

📍

Location

WENZHOU

🇨🇳

Country

CHINA
🏢

Address

4/FL BLUE SKY BUSINESSCENTER, 18 MOGANSHAN ROAD, WENZHOU, , China

Low Risk

FDA Import Risk Assessment

24.8
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/3/2021
Latest Refusal
11/3/2021
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
2.2×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
11/3/2021
80OVRKIT, FIRST AID, TALKING
3280FRNMFGREG
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD's FDA import refusal history?

ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD (FEI: 3020176146) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2021 to 11/3/2021.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD's FEI number is 3020176146.

What types of violations has ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD received?

ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD come from?

All FDA import refusal data for ZHEJIANG KANG LI DI MEDICAL ARTICLES CO. LTD is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.