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Amcor Plastube North America

⚠️ Moderate Risk

FEI: 3002922114 • Granby, Quebec • CANADA

FEI

FEI Number

3002922114

📍

Location

Granby, Quebec

🇨🇦

Country

CANADA
🏢

Address

590 Simonds St S, , Granby, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

49.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/13/2023
Latest Refusal
6/13/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
47.8×20%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
6/13/2023
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Amcor Plastube North America's FDA import refusal history?

Amcor Plastube North America (FEI: 3002922114) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2023 to 6/13/2023.

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. Amcor Plastube North America's FEI number is 3002922114.

What types of violations has Amcor Plastube North America received?

Amcor Plastube North America 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 Amcor Plastube North America come from?

All FDA import refusal data for Amcor Plastube North America 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.