ImportRefusal LogoImportRefusal

Breakwell Education

⚠️ Moderate Risk

FEI: 3008738360 • Stratford, ON • CANADA

FEI

FEI Number

3008738360

📍

Location

Stratford, ON

🇨🇦

Country

CANADA
🏢

Address

45 Waterloo St S., , Stratford, ON, Canada

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
2/11/2011
Latest Refusal
2/11/2011
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

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
2/11/2011
61TCA31DOMPERIDONE
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Breakwell Education's FDA import refusal history?

Breakwell Education (FEI: 3008738360) has 1 FDA import refusal record(s) in our database, spanning from 2/11/2011 to 2/11/2011.

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. Breakwell Education's FEI number is 3008738360.

What types of violations has Breakwell Education received?

Breakwell Education 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 Breakwell Education come from?

All FDA import refusal data for Breakwell Education 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.