Essiac Canada International
⚠️ Moderate Risk
FEI: 3004796236 • Ottawa, Ontario • CANADA
FEI Number
3004796236
Location
Ottawa, Ontario
Country
CANADAAddress
Po Box 23155 Rpo Carlingwood, , Ottawa, Ontario, 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).
Refusal History
Frequently Asked Questions
What is Essiac Canada International's FDA import refusal history?
Essiac Canada International (FEI: 3004796236) has 2 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 8/5/2011.
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. Essiac Canada International's FEI number is 3004796236.
What types of violations has Essiac Canada International received?
Essiac Canada International has been cited for 1 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 Essiac Canada International come from?
All FDA import refusal data for Essiac Canada 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.