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YIWU XUTAI OUTDOOR CAMPING PRODUCTS

⚠️ Moderate Risk

FEI: 3020919351 • Zhejiang • CHINA

FEI

FEI Number

3020919351

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

3 Floor, 1 Huajin Road,Jinhua, , Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/20/2021
Latest Refusal
12/20/2021
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
4.8×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/20/2021
80PDHBLANKET, NEONATAL PHOTOTHERAPY
118NOT LISTED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is YIWU XUTAI OUTDOOR CAMPING PRODUCTS's FDA import refusal history?

YIWU XUTAI OUTDOOR CAMPING PRODUCTS (FEI: 3020919351) has 1 FDA import refusal record(s) in our database, spanning from 12/20/2021 to 12/20/2021.

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. YIWU XUTAI OUTDOOR CAMPING PRODUCTS's FEI number is 3020919351.

What types of violations has YIWU XUTAI OUTDOOR CAMPING PRODUCTS received?

YIWU XUTAI OUTDOOR CAMPING PRODUCTS 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 YIWU XUTAI OUTDOOR CAMPING PRODUCTS come from?

All FDA import refusal data for YIWU XUTAI OUTDOOR CAMPING PRODUCTS 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.