Outer Coast Seaweeds Ltd
⚠️ High Risk
FEI: 3010421379 • Sooke, BC • CANADA
FEI Number
3010421379
Location
Sooke, BC
Country
CANADAAddress
2105 Otter Point Road, , Sooke, BC, 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/24/2014 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 11/13/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 11/13/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 8/22/2013 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Outer Coast Seaweeds Ltd's FDA import refusal history?
Outer Coast Seaweeds Ltd (FEI: 3010421379) has 18 FDA import refusal record(s) in our database, spanning from 8/22/2013 to 9/24/2014.
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. Outer Coast Seaweeds Ltd's FEI number is 3010421379.
What types of violations has Outer Coast Seaweeds Ltd received?
Outer Coast Seaweeds Ltd 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 Outer Coast Seaweeds Ltd come from?
All FDA import refusal data for Outer Coast Seaweeds 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.