Vegewax Candleworx Ltd.
⚠️ High Risk
FEI: 3005787511 • Concord, Ontario • CANADA
FEI Number
3005787511
Location
Concord, Ontario
Country
CANADAAddress
300 North Rivermede Rd, , Concord, Ontario, 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
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).
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).
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of Northern Border Imports (DNBI) | |
| 8/24/2018 | 62MDJ08MENTHOL (ANTI-PRURITIC) | Division of Northern Border Imports (DNBI) | |
| 10/19/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Detroit District Office (DET-DO) | |
| 10/19/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Detroit District Office (DET-DO) | |
| 1/26/2010 | 65LAJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 12/17/2009 | 55PY70CETYL ALCOHOL (PHARMACEUTIC NECESSITY - EMULSIFYING & STIFFENING AGENT) | New York District Office (NYK-DO) | |
| 12/1/2009 | 62MBL08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Vegewax Candleworx Ltd.'s FDA import refusal history?
Vegewax Candleworx Ltd. (FEI: 3005787511) has 7 FDA import refusal record(s) in our database, spanning from 12/1/2009 to 6/25/2025.
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. Vegewax Candleworx Ltd.'s FEI number is 3005787511.
What types of violations has Vegewax Candleworx Ltd. received?
Vegewax Candleworx Ltd. has been cited for 7 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 Vegewax Candleworx Ltd. come from?
All FDA import refusal data for Vegewax Candleworx Ltd. 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.