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GE Medical Systems Monterrey Mexico SA de CV

⚠️ Moderate Risk

FEI: 3003377038 • Apodaca • MEXICO

FEI

FEI Number

3003377038

📍

Location

Apodaca

🇲🇽

Country

MEXICO
🏢

Address

Espana 300 Parque Industrial Huinala, , Apodaca, , Mexico

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/28/2014
Latest Refusal
2/28/2014
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
2/28/2014
90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is GE Medical Systems Monterrey Mexico SA de CV's FDA import refusal history?

GE Medical Systems Monterrey Mexico SA de CV (FEI: 3003377038) has 1 FDA import refusal record(s) in our database, spanning from 2/28/2014 to 2/28/2014.

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 Medical Systems Monterrey Mexico SA de CV's FEI number is 3003377038.

What types of violations has GE Medical Systems Monterrey Mexico SA de CV received?

GE Medical Systems Monterrey Mexico SA de CV 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 Medical Systems Monterrey Mexico SA de CV come from?

All FDA import refusal data for GE Medical Systems Monterrey Mexico SA de CV 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.