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AMCOR FLEXIBLES

⚠️ Moderate Risk

FEI: 3012469461 • Coulommiers, Seine Et Marne • FRANCE

FEI

FEI Number

3012469461

📍

Location

Coulommiers, Seine Et Marne

🇫🇷

Country

FRANCE
🏢

Address

5 rue de Montigny, , Coulommiers, Seine Et Marne, France

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/28/2018
Latest Refusal
6/28/2018
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

32803×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
6/28/2018
80FRGWRAP, STERILIZATION
3280FRNMFGREG
341REGISTERED
Division of Northern Border Imports (DNBI)
6/28/2018
80FRGWRAP, STERILIZATION
3280FRNMFGREG
341REGISTERED
Division of Northern Border Imports (DNBI)
6/28/2018
80FRGWRAP, STERILIZATION
3280FRNMFGREG
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is AMCOR FLEXIBLES's FDA import refusal history?

AMCOR FLEXIBLES (FEI: 3012469461) has 3 FDA import refusal record(s) in our database, spanning from 6/28/2018 to 6/28/2018.

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. AMCOR FLEXIBLES's FEI number is 3012469461.

What types of violations has AMCOR FLEXIBLES received?

AMCOR FLEXIBLES has been cited for 2 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 AMCOR FLEXIBLES come from?

All FDA import refusal data for AMCOR FLEXIBLES 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.