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Mc David Knee Guard Inc

✅ Low Risk

FEI: 1000366805 • Downers Grove, IL • UNITED STATES

FEI

FEI Number

1000366805

📍

Location

Downers Grove, IL

🇺🇸
🏢

Address

10305 Argonne Dr, , Downers Grove, IL, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
2/25/2008
Latest Refusal
2/25/2008
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

Refusal History

DateProductViolationsDivision
2/25/2008
79KGXTAPE AND BANDAGE, ADHESIVE
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mc David Knee Guard Inc's FDA import refusal history?

Mc David Knee Guard Inc (FEI: 1000366805) has 1 FDA import refusal record(s) in our database, spanning from 2/25/2008 to 2/25/2008.

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. Mc David Knee Guard Inc's FEI number is 1000366805.

What types of violations has Mc David Knee Guard Inc received?

Mc David Knee Guard Inc 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 Mc David Knee Guard Inc come from?

All FDA import refusal data for Mc David Knee Guard 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.