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Brasserie Maltco Inc.

⚠️ Moderate Risk

FEI: 3017166127 • Quebec, Quebec • CANADA

FEI

FEI Number

3017166127

📍

Location

Quebec, Quebec

🇨🇦

Country

CANADA
🏢

Address

1750 Rue Du Perigord, , Quebec, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

48.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/15/2023
Latest Refusal
12/15/2023
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
58.0×20%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

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
12/15/2023
29SYE07SPARKLING WATER, CARBONATED WATER (NONMEDICINAL)
2280DIRSEXMPT
238UNSAFE ADD
75UNAPPROVED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Brasserie Maltco Inc.'s FDA import refusal history?

Brasserie Maltco Inc. (FEI: 3017166127) has 1 FDA import refusal record(s) in our database, spanning from 12/15/2023 to 12/15/2023.

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. Brasserie Maltco Inc.'s FEI number is 3017166127.

What types of violations has Brasserie Maltco Inc. received?

Brasserie Maltco Inc. has been cited for 3 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 Brasserie Maltco Inc. come from?

All FDA import refusal data for Brasserie Maltco Inc. 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.