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GE BE Private Limited

⚠️ Moderate Risk

FEI: 3002874382 • Bengaluru, Karnataka • INDIA

FEI

FEI Number

3002874382

📍

Location

Bengaluru, Karnataka

🇮🇳

Country

INDIA
🏢

Address

60 International School Of Management Excellence, , Bengaluru, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

25.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/7/2023
Latest Refusal
4/7/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
44.1×20%
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
4/7/2023
90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GE BE Private Limited's FDA import refusal history?

GE BE Private Limited (FEI: 3002874382) has 1 FDA import refusal record(s) in our database, spanning from 4/7/2023 to 4/7/2023.

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. GE BE Private Limited's FEI number is 3002874382.

What types of violations has GE BE Private Limited received?

GE BE Private Limited 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 GE BE Private Limited come from?

All FDA import refusal data for GE BE Private Limited 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.