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HUBEI RUILIHEN PROTECTIVE EQUIPMENT CO. LTD

⚠️ Moderate Risk

FEI: 3038688102 • Xiantao, Hubei • CHINA

FEI

FEI Number

3038688102

📍

Location

Xiantao, Hubei

🇨🇳

Country

CHINA
🏢

Address

1 Yewang Community Garden Longhua Mountain, , Xiantao, Hubei, China

Moderate Risk

FDA Import Risk Assessment

34.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/30/2025
Latest Refusal
7/30/2025
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
91.0×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
7/30/2025
80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is HUBEI RUILIHEN PROTECTIVE EQUIPMENT CO. LTD's FDA import refusal history?

HUBEI RUILIHEN PROTECTIVE EQUIPMENT CO. LTD (FEI: 3038688102) has 1 FDA import refusal record(s) in our database, spanning from 7/30/2025 to 7/30/2025.

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. HUBEI RUILIHEN PROTECTIVE EQUIPMENT CO. LTD's FEI number is 3038688102.

What types of violations has HUBEI RUILIHEN PROTECTIVE EQUIPMENT CO. LTD received?

HUBEI RUILIHEN PROTECTIVE EQUIPMENT 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 HUBEI RUILIHEN PROTECTIVE EQUIPMENT CO. LTD come from?

All FDA import refusal data for HUBEI RUILIHEN PROTECTIVE EQUIPMENT 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.