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Trillium Health Care Products Inc.

⚠️ Moderate Risk

FEI: 3003207717 • Perth, Ontario • CANADA

FEI

FEI Number

3003207717

📍

Location

Perth, Ontario

🇨🇦

Country

CANADA
🏢

Address

5 Herriott St, , Perth, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/6/2003
Latest Refusal
1/13/2003
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
6/6/2003
53BD02BUBBLE BATHS (BATH PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
6/6/2003
53BD02BUBBLE BATHS (BATH PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
1/13/2003
64AB20TRICLOSAN (DISINFECTANT)
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Trillium Health Care Products Inc.'s FDA import refusal history?

Trillium Health Care Products Inc. (FEI: 3003207717) has 3 FDA import refusal record(s) in our database, spanning from 1/13/2003 to 6/6/2003.

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. Trillium Health Care Products Inc.'s FEI number is 3003207717.

What types of violations has Trillium Health Care Products Inc. received?

Trillium Health Care Products Inc. 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 Trillium Health Care Products Inc. come from?

All FDA import refusal data for Trillium Health Care Products 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.