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MARKEM IMAJE SA

✅ Low Risk

FEI: 3012487632 • Bourg les Valence CEDEX, Drome • FRANCE

FEI

FEI Number

3012487632

📍

Location

Bourg les Valence CEDEX, Drome

🇫🇷

Country

FRANCE
🏢

Address

Impression a Jet D Encre, 9 rue Gaspard Monge; Cs 70110, Bourg les Valence CEDEX, Drome, France

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
1/25/2017
Latest Refusal
1/25/2017
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
1/25/2017
79OHOFIRST AID KIT WITHOUT DRUG
118NOT LISTED
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is MARKEM IMAJE SA's FDA import refusal history?

MARKEM IMAJE SA (FEI: 3012487632) has 1 FDA import refusal record(s) in our database, spanning from 1/25/2017 to 1/25/2017.

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. MARKEM IMAJE SA's FEI number is 3012487632.

What types of violations has MARKEM IMAJE SA received?

MARKEM IMAJE SA 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 MARKEM IMAJE SA come from?

All FDA import refusal data for MARKEM IMAJE SA 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.