Trillium Health Care Products
⚠️ Moderate Risk
FEI: 2000037655 • Prescott, Ontario • CANADA
FEI Number
2000037655
Location
Prescott, Ontario
Country
CANADAAddress
606 Hyde Street, , Prescott, Ontario, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2004 | 64AAL20TRICLOSAN (DISINFECTANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/29/2003 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 7/29/2003 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 7/29/2003 | 53BD02BUBBLE BATHS (BATH PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 1/13/2003 | 64ABL20TRICLOSAN (DISINFECTANT) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Trillium Health Care Products's FDA import refusal history?
Trillium Health Care Products (FEI: 2000037655) has 5 FDA import refusal record(s) in our database, spanning from 1/13/2003 to 11/22/2004.
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's FEI number is 2000037655.
What types of violations has Trillium Health Care Products received?
Trillium Health Care Products 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 come from?
All FDA import refusal data for Trillium Health Care Products 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.