Alera Skin Care Products
⚠️ Moderate Risk
FEI: 3012395785 • Burnaby, British Columbia • CANADA
FEI Number
3012395785
Location
Burnaby, British Columbia
Country
CANADAAddress
4268 Lozells Ave Unit 110, , Burnaby, British Columbia, 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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2019 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 60QAO67LIDOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/3/2019 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 11/7/2019 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 10/31/2019 | 60QAL67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/21/2019 | 60QBL67LIDOCAINE (ANESTHETIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Alera Skin Care Products's FDA import refusal history?
Alera Skin Care Products (FEI: 3012395785) has 16 FDA import refusal record(s) in our database, spanning from 5/21/2019 to 12/3/2019.
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. Alera Skin Care Products's FEI number is 3012395785.
What types of violations has Alera Skin Care Products received?
Alera Skin Care Products has been cited for 4 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 Alera Skin Care Products come from?
All FDA import refusal data for Alera Skin 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.