Sedna International
⚠️ High Risk
FEI: 3005769953 • Saint-Hubert, Quebec • CANADA
FEI Number
3005769953
Location
Saint-Hubert, Quebec
Country
CANADAAddress
5435 J.-a.-Bombardier St, , Saint-Hubert, 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).
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2013 | 53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 53UY12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/17/2013 | 53UY12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 7/3/2012 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/3/2012 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 7/3/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New York District Office (NYK-DO) | |
| 6/28/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/28/2012 | 53UY12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | New York District Office (NYK-DO) | |
| 6/28/2012 | 53UY12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | New York District Office (NYK-DO) | |
| 6/28/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/28/2012 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sedna International's FDA import refusal history?
Sedna International (FEI: 3005769953) has 31 FDA import refusal record(s) in our database, spanning from 6/28/2012 to 5/17/2013.
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. Sedna International's FEI number is 3005769953.
What types of violations has Sedna International received?
Sedna International 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 Sedna International come from?
All FDA import refusal data for Sedna International 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.