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NOVANTA EUROPE GMBH

⚠️ Moderate Risk

FEI: 3018249396 • Wackersdorf, Bavaria • GERMANY

FEI

FEI Number

3018249396

📍

Location

Wackersdorf, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Werk 4, , Wackersdorf, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

37.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/14/2023
Latest Refusal
2/14/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
27.8×20%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
2/14/2023
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NOVANTA EUROPE GMBH's FDA import refusal history?

NOVANTA EUROPE GMBH (FEI: 3018249396) has 1 FDA import refusal record(s) in our database, spanning from 2/14/2023 to 2/14/2023.

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. NOVANTA EUROPE GMBH's FEI number is 3018249396.

What types of violations has NOVANTA EUROPE GMBH received?

NOVANTA EUROPE GMBH 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 NOVANTA EUROPE GMBH come from?

All FDA import refusal data for NOVANTA EUROPE GMBH 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.