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ORIENT GENE THE SENSUS GROUP

⚠️ Moderate Risk

FEI: 3021378379 • Sawbridgeworth • UNITED KINGDOM

FEI

FEI Number

3021378379

📍

Location

Sawbridgeworth

🇬🇧
🏢

Address

Tha Barn Tednambury Far, , Sawbridgeworth, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

26.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/22/2022
Latest Refusal
2/22/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
8.3×20%
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
2/22/2022
83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ORIENT GENE THE SENSUS GROUP's FDA import refusal history?

ORIENT GENE THE SENSUS GROUP (FEI: 3021378379) has 1 FDA import refusal record(s) in our database, spanning from 2/22/2022 to 2/22/2022.

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. ORIENT GENE THE SENSUS GROUP's FEI number is 3021378379.

What types of violations has ORIENT GENE THE SENSUS GROUP received?

ORIENT GENE THE SENSUS GROUP 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 ORIENT GENE THE SENSUS GROUP come from?

All FDA import refusal data for ORIENT GENE THE SENSUS GROUP 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.