Les Emballages Facoteck Inc
⚠️ High Risk
FEI: 3002955163 • Scotstown, Quebec • CANADA
FEI Number
3002955163
Location
Scotstown, Quebec
Country
CANADAAddress
35 Ch Victoria W Bureau 236, , Scotstown, Quebec, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
INCONSPICU
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2025 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/1/2017 | 54AYH99VITAMIN, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/1/2017 | 54AYH99VITAMIN, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/1/2017 | 54AYH99VITAMIN, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/1/2017 | 54AYH99VITAMIN, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/1/2017 | 54AYH99VITAMIN, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/21/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 5/17/2013 | 54HCH05OMEGA-3 (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 54BCH99MINERAL N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 54HCH05OMEGA-3 (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 12/5/2011 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/5/2011 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/5/2011 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 12/5/2011 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 8/17/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/17/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 12/7/2009 | 60LBJ99ANALGESIC, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Les Emballages Facoteck Inc's FDA import refusal history?
Les Emballages Facoteck Inc (FEI: 3002955163) has 17 FDA import refusal record(s) in our database, spanning from 12/7/2009 to 5/12/2025.
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. Les Emballages Facoteck Inc's FEI number is 3002955163.
What types of violations has Les Emballages Facoteck Inc received?
Les Emballages Facoteck Inc has been cited for 6 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 Les Emballages Facoteck Inc come from?
All FDA import refusal data for Les Emballages Facoteck 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.