ImportRefusal LogoImportRefusal

GE HEALTHCARE MANUFACTURING LLC

⚠️ High Risk

FEI: 3022929772 • Florence, SC • UNITED STATES

FEI

FEI Number

3022929772

📍

Location

Florence, SC

🇺🇸
🏢

Address

3001 W Radio Dr, , Florence, SC, United States

High Risk

FDA Import Risk Assessment

50.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
7/15/2025
Latest Refusal
7/15/2025
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
90.0×20%
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

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
7/15/2025
90LNHSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
479DV QUALITY
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is GE HEALTHCARE MANUFACTURING LLC's FDA import refusal history?

GE HEALTHCARE MANUFACTURING LLC (FEI: 3022929772) has 1 FDA import refusal record(s) in our database, spanning from 7/15/2025 to 7/15/2025.

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. GE HEALTHCARE MANUFACTURING LLC's FEI number is 3022929772.

What types of violations has GE HEALTHCARE MANUFACTURING LLC received?

GE HEALTHCARE MANUFACTURING LLC 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 HEALTHCARE MANUFACTURING LLC come from?

All FDA import refusal data for GE HEALTHCARE MANUFACTURING LLC 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.