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HENAN GEESION MEDICAL DEVICES COLTD

⚠️ Moderate Risk

FEI: 3039906685 • Dover, DE • UNITED STATES

FEI

FEI Number

3039906685

📍

Location

Dover, DE

🇺🇸
🏢

Address

19 Holly Cove Ln, , Dover, DE, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/26/2025
Latest Refusal
9/26/2025
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
79.8×20%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
9/26/2025
89OMWADHESIVE BACKED THERMAL SKIN PATCHES
3260NO ENGLISH
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is HENAN GEESION MEDICAL DEVICES COLTD's FDA import refusal history?

HENAN GEESION MEDICAL DEVICES COLTD (FEI: 3039906685) has 1 FDA import refusal record(s) in our database, spanning from 9/26/2025 to 9/26/2025.

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. HENAN GEESION MEDICAL DEVICES COLTD's FEI number is 3039906685.

What types of violations has HENAN GEESION MEDICAL DEVICES COLTD received?

HENAN GEESION MEDICAL DEVICES COLTD 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 HENAN GEESION MEDICAL DEVICES COLTD come from?

All FDA import refusal data for HENAN GEESION MEDICAL DEVICES COLTD 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.