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Coretection

⚠️ Moderate Risk

FEI: 3005948588 • Abbotsford, BC • CANADA

FEI

FEI Number

3005948588

📍

Location

Abbotsford, BC

🇨🇦

Country

CANADA
🏢

Address

110 - 3600 Townline Rd, , Abbotsford, BC, Canada

Moderate Risk

FDA Import Risk Assessment

33.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
10/30/2006
Latest Refusal
10/30/2006
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

3334×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

754×

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
10/30/2006
60LBJ99ANALGESIC, N.E.C.
333LACKS FIRM
75UNAPPROVED
Seattle District Office (SEA-DO)
10/30/2006
60LBJ99ANALGESIC, N.E.C.
333LACKS FIRM
75UNAPPROVED
Seattle District Office (SEA-DO)
10/30/2006
60LBJ99ANALGESIC, N.E.C.
333LACKS FIRM
75UNAPPROVED
Seattle District Office (SEA-DO)
10/30/2006
60LBJ99ANALGESIC, N.E.C.
333LACKS FIRM
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Coretection's FDA import refusal history?

Coretection (FEI: 3005948588) has 4 FDA import refusal record(s) in our database, spanning from 10/30/2006 to 10/30/2006.

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. Coretection's FEI number is 3005948588.

What types of violations has Coretection received?

Coretection 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 Coretection come from?

All FDA import refusal data for Coretection 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.