ImportRefusal LogoImportRefusal

Shoppers Drug Mart Mccauleys

⚠️ Moderate Risk

FEI: 3003478263 • Hamilton, Ontario • CANADA

FEI

FEI Number

3003478263

📍

Location

Hamilton, Ontario

🇨🇦

Country

CANADA
🏢

Address

On, 113 Herkimer St, Hamilton, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/4/2001
Latest Refusal
12/4/2001
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

751×

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
12/4/2001
61FDF54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
179AGR RX
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Shoppers Drug Mart Mccauleys's FDA import refusal history?

Shoppers Drug Mart Mccauleys (FEI: 3003478263) has 1 FDA import refusal record(s) in our database, spanning from 12/4/2001 to 12/4/2001.

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. Shoppers Drug Mart Mccauleys's FEI number is 3003478263.

What types of violations has Shoppers Drug Mart Mccauleys received?

Shoppers Drug Mart Mccauleys 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 Shoppers Drug Mart Mccauleys come from?

All FDA import refusal data for Shoppers Drug Mart Mccauleys 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.