Prairie Naturals Health Products
⚠️ Moderate Risk
FEI: 3007079655 • Coquitlam, British Columbia • CANADA
FEI Number
3007079655
Location
Coquitlam, British Columbia
Country
CANADAAddress
56 Fawcett Rd, , Coquitlam, 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
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 |
|---|---|---|---|
| 11/29/2018 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/21/2018 | 60CAA22EPHEDRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/7/2015 | 60CAY21EPHEDRINE (ADRENERGIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Prairie Naturals Health Products's FDA import refusal history?
Prairie Naturals Health Products (FEI: 3007079655) has 3 FDA import refusal record(s) in our database, spanning from 8/7/2015 to 11/29/2018.
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. Prairie Naturals Health Products's FEI number is 3007079655.
What types of violations has Prairie Naturals Health Products received?
Prairie Naturals Health Products 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 Prairie Naturals Health Products come from?
All FDA import refusal data for Prairie Naturals Health Products 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.