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PACKAGING DEPOT EDMONTON

⚠️ Moderate Risk

FEI: 3017202366 • Edmonton, Alberta • CANADA

FEI

FEI Number

3017202366

📍

Location

Edmonton, Alberta

🇨🇦

Country

CANADA
🏢

Address

6641 177 St Nw, , Edmonton, Alberta, Canada

Moderate Risk

FDA Import Risk Assessment

44.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/31/2022
Latest Refusal
1/31/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
5.8×20%
Frequency
20.0×10%
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

752×

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
1/31/2022
61PCY17INSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/31/2022
61PCY17INSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PACKAGING DEPOT EDMONTON's FDA import refusal history?

PACKAGING DEPOT EDMONTON (FEI: 3017202366) has 2 FDA import refusal record(s) in our database, spanning from 1/31/2022 to 1/31/2022.

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. PACKAGING DEPOT EDMONTON's FEI number is 3017202366.

What types of violations has PACKAGING DEPOT EDMONTON received?

PACKAGING DEPOT EDMONTON 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 PACKAGING DEPOT EDMONTON come from?

All FDA import refusal data for PACKAGING DEPOT EDMONTON 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.