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Marel Corporation

⚠️ Moderate Risk

FEI: 3001596577 • West Haven, CT • UNITED STATES

FEI

FEI Number

3001596577

📍

Location

West Haven, CT

🇺🇸
🏢

Address

5 Saw Mill Rd, , West 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
4/28/2014
Latest Refusal
4/28/2014
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

781×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
4/28/2014
79EFQSPONGE, GAUZE
78STERILITY
New York District Office (NYK-DO)

Frequently Asked Questions

What is Marel Corporation's FDA import refusal history?

Marel Corporation (FEI: 3001596577) has 1 FDA import refusal record(s) in our database, spanning from 4/28/2014 to 4/28/2014.

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. Marel Corporation's FEI number is 3001596577.

What types of violations has Marel Corporation received?

Marel Corporation 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 Marel Corporation come from?

All FDA import refusal data for Marel Corporation 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.