Andre Clark
⚠️ Moderate Risk
FEI: 3009678900 • Winnipegwinnipeg, MANITOBA • CANADA
FEI Number
3009678900
Location
Winnipegwinnipeg, MANITOBA
Country
CANADAAddress
502 Berwick Pl, , Winnipegwinnipeg, MANITOBA, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is Andre Clark's FDA import refusal history?
Andre Clark (FEI: 3009678900) has 1 FDA import refusal record(s) in our database, spanning from 8/16/2012 to 8/16/2012.
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. Andre Clark's FEI number is 3009678900.
What types of violations has Andre Clark received?
Andre Clark 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 Andre Clark come from?
All FDA import refusal data for Andre Clark 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.