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CERABETA

⚠️ Moderate Risk

FEI: 3030341449 • Edmonton, Alberta • CANADA

FEI

FEI Number

3030341449

📍

Location

Edmonton, Alberta

🇨🇦

Country

CANADA
🏢

Address

9411 63 Ave Nw Suite 250, , Edmonton, Alberta, Canada

Moderate Risk

FDA Import Risk Assessment

35.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/25/2024
Latest Refusal
3/25/2024
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
63.6×20%
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

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
3/25/2024
54IBR99FIBER, N.E.C.
260FALSE
473LABELING
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is CERABETA's FDA import refusal history?

CERABETA (FEI: 3030341449) has 1 FDA import refusal record(s) in our database, spanning from 3/25/2024 to 3/25/2024.

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. CERABETA's FEI number is 3030341449.

What types of violations has CERABETA received?

CERABETA 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 CERABETA come from?

All FDA import refusal data for CERABETA 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.