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Integrated Fulfillment Management Services Inc

⚠️ Moderate Risk

FEI: 3003917710 • Delta, BC • CANADA

FEI

FEI Number

3003917710

📍

Location

Delta, BC

🇨🇦

Country

CANADA
🏢

Address

7107 Venture St /#6 Bc, , Delta, BC, Canada

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/15/2008
Latest Refusal
7/15/2008
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
7/15/2008
75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
118NOT LISTED
508NO 510(K)
Seattle District Office (SEA-DO)
7/15/2008
75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
118NOT LISTED
508NO 510(K)
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Integrated Fulfillment Management Services Inc's FDA import refusal history?

Integrated Fulfillment Management Services Inc (FEI: 3003917710) has 2 FDA import refusal record(s) in our database, spanning from 7/15/2008 to 7/15/2008.

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. Integrated Fulfillment Management Services Inc's FEI number is 3003917710.

What types of violations has Integrated Fulfillment Management Services Inc received?

Integrated Fulfillment Management Services Inc 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 Integrated Fulfillment Management Services Inc come from?

All FDA import refusal data for Integrated Fulfillment Management Services Inc 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.