Bodywell Natural Skin Care Inc.
⚠️ High Risk
FEI: 3018011294 • Delta, British Columbia • CANADA
FEI Number
3018011294
Location
Delta, British Columbia
Country
CANADAAddress
7338 Progress Way Unit 3, , Delta, British Columbia, 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).
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 |
|---|---|---|---|
| 12/13/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/13/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/13/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/13/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/13/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 12/13/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 7/18/2023 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/10/2023 | 62FAK99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Bodywell Natural Skin Care Inc.'s FDA import refusal history?
Bodywell Natural Skin Care Inc. (FEI: 3018011294) has 8 FDA import refusal record(s) in our database, spanning from 7/10/2023 to 12/13/2024.
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. Bodywell Natural Skin Care Inc.'s FEI number is 3018011294.
What types of violations has Bodywell Natural Skin Care Inc. received?
Bodywell Natural Skin Care Inc. has been cited for 3 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 Bodywell Natural Skin Care Inc. come from?
All FDA import refusal data for Bodywell Natural Skin Care 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.