Trans-Herbe, Inc.
⚠️ Moderate Risk
FEI: 3003296163 • Saint-bruno, Quebec • CANADA
FEI Number
3003296163
Location
Saint-bruno, Quebec
Country
CANADAAddress
1090 Parent St, , Saint-bruno, Quebec, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/15/2014 | 31KFH02TEA, GREEN | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/11/2014 | 61KDR99ANTI-CHOLINERGIC, N.E.C. | Detroit District Office (DET-DO) | |
| 12/17/2013 | 54EBT99HERBALS & BOTANICAL TEAS, N.E.C. | 249FILTHY | Detroit District Office (DET-DO) |
| 11/7/2011 | 54EBT99HERBALS & BOTANICAL TEAS, N.E.C. | New York District Office (NYK-DO) | |
| 10/27/2011 | 66VDS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 10/27/2011 | 66VDS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 10/27/2011 | 66VDS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 12/12/2003 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Trans-Herbe, Inc.'s FDA import refusal history?
Trans-Herbe, Inc. (FEI: 3003296163) has 8 FDA import refusal record(s) in our database, spanning from 12/12/2003 to 10/15/2014.
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. Trans-Herbe, Inc.'s FEI number is 3003296163.
What types of violations has Trans-Herbe, Inc. received?
Trans-Herbe, Inc. has been cited for 9 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 Trans-Herbe, Inc. come from?
All FDA import refusal data for Trans-Herbe, 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.