ImportRefusal LogoImportRefusal

Medicine Shoppe #185

⚠️ Moderate Risk

FEI: 3009686845 • Edmontonedmonton, ALBERTA • CANADA

FEI

FEI Number

3009686845

📍

Location

Edmontonedmonton, ALBERTA

🇨🇦

Country

CANADA
🏢

Address

8219 112 St Nw, , Edmontonedmonton, ALBERTA, Canada

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
8/29/2012
Latest Refusal
8/29/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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

DateProductViolationsDivision
8/29/2012
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/29/2012
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/29/2012
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Medicine Shoppe #185's FDA import refusal history?

Medicine Shoppe #185 (FEI: 3009686845) has 3 FDA import refusal record(s) in our database, spanning from 8/29/2012 to 8/29/2012.

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. Medicine Shoppe #185's FEI number is 3009686845.

What types of violations has Medicine Shoppe #185 received?

Medicine Shoppe #185 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 Medicine Shoppe #185 come from?

All FDA import refusal data for Medicine Shoppe #185 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.