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Armstrong Medical Industries Inc.

⚠️ Moderate Risk

FEI: 1419843 • Lincolnshire, IL • UNITED STATES

FEI

FEI Number

1419843

📍

Location

Lincolnshire, IL

🇺🇸
🏢

Address

575 Knightsbridge Pkwy, , Lincolnshire, IL, United States

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/4/2008
Latest Refusal
5/23/2008
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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).

33401×

DE/RX KIT

The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is 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.

Refusal History

DateProductViolationsDivision
8/4/2008
80JOKSCISSORS, MEDICAL, DISPOSABLE
118NOT LISTED
Chicago District Office (CHI-DO)
5/23/2008
80JOKSCISSORS, MEDICAL, DISPOSABLE
118NOT LISTED
3340DE/RX KIT
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Armstrong Medical Industries Inc.'s FDA import refusal history?

Armstrong Medical Industries Inc. (FEI: 1419843) has 2 FDA import refusal record(s) in our database, spanning from 5/23/2008 to 8/4/2008.

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. Armstrong Medical Industries Inc.'s FEI number is 1419843.

What types of violations has Armstrong Medical Industries Inc. received?

Armstrong Medical Industries 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 Armstrong Medical Industries Inc. come from?

All FDA import refusal data for Armstrong Medical Industries 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.