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GE PHARMA LLC

⚠️ Moderate Risk

FEI: 3009202291 • North Haven, CT • UNITED STATES

FEI

FEI Number

3009202291

📍

Location

North Haven, CT

🇺🇸
🏢

Address

55 Middletown Ave Fl 2, , North Haven, CT, United States

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/19/2012
Latest Refusal
11/19/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

31201×

EPHEDALK

The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.

Refusal History

DateProductViolationsDivision
11/19/2012
54YEH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3120EPHEDALK
New York District Office (NYK-DO)

Frequently Asked Questions

What is GE PHARMA LLC's FDA import refusal history?

GE PHARMA LLC (FEI: 3009202291) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2012 to 11/19/2012.

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 PHARMA LLC's FEI number is 3009202291.

What types of violations has GE PHARMA LLC received?

GE PHARMA 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 PHARMA LLC come from?

All FDA import refusal data for GE PHARMA 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.