Sisu Enterprises Co Inc
⚠️ Moderate Risk
FEI: 3002345819 • Burnaby, British Columbia • CANADA
FEI Number
3002345819
Location
Burnaby, British Columbia
Country
CANADAAddress
3430 Brighton Ave, , Burnaby, British Columbia, 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
SBGINSENG
The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/16/2006 | 54YIY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 473LABELING | New Orleans District Office (NOL-DO) |
| 5/19/2005 | 54HCH04FISH OIL (FATS AND LIPID SUBSTANCES) | 482NUTRIT LBL | Seattle District Office (SEA-DO) |
| 9/17/2004 | 54YCE04GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALS | 3140SBGINSENG | Seattle District Office (SEA-DO) |
| 5/7/2002 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Sisu Enterprises Co Inc's FDA import refusal history?
Sisu Enterprises Co Inc (FEI: 3002345819) has 4 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 2/16/2006.
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. Sisu Enterprises Co Inc's FEI number is 3002345819.
What types of violations has Sisu Enterprises Co Inc received?
Sisu Enterprises Co Inc has been cited for 4 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 Sisu Enterprises Co Inc come from?
All FDA import refusal data for Sisu Enterprises Co 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.