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STILMAS AMERICAS INC.

⚠️ Moderate Risk

FEI: 3003405938 • Burlington, Ontario • CANADA

FEI

FEI Number

3003405938

📍

Location

Burlington, Ontario

🇨🇦

Country

CANADA
🏢

Address

3250 Harvester Rd Unit 6, , Burlington, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/9/2021
Latest Refusal
9/9/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
9/9/2021
95RAALASER PRODUCTS (PRE-STANDARD)
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is STILMAS AMERICAS INC.'s FDA import refusal history?

STILMAS AMERICAS INC. (FEI: 3003405938) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2021 to 9/9/2021.

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. STILMAS AMERICAS INC.'s FEI number is 3003405938.

What types of violations has STILMAS AMERICAS INC. received?

STILMAS AMERICAS INC. 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 STILMAS AMERICAS INC. come from?

All FDA import refusal data for STILMAS AMERICAS 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.