BIOCEAN CANADA
⚠️ Moderate Risk
FEI: 3007500917 • Sherbrooke, Quebec • CANADA
FEI Number
3007500917
Location
Sherbrooke, Quebec
Country
CANADAAddress
280 Rue Marquette, , Sherbrooke, Quebec, 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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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 | 53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 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) |
| 5/17/2013 | 53UY12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 2/5/2013 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 2/5/2013 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BIOCEAN CANADA's FDA import refusal history?
BIOCEAN CANADA (FEI: 3007500917) has 7 FDA import refusal record(s) in our database, spanning from 2/5/2013 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. BIOCEAN CANADA's FEI number is 3007500917.
What types of violations has BIOCEAN CANADA received?
BIOCEAN CANADA has been cited for 2 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 BIOCEAN CANADA come from?
All FDA import refusal data for BIOCEAN CANADA 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.