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Cardinal Health Inc.

⚠️ Moderate Risk

FEI: 1000148701 • Chicopee, MA • UNITED STATES

FEI

FEI Number

1000148701

📍

Location

Chicopee, MA

🇺🇸
🏢

Address

2 Ludlow Park Dr, , Chicopee, MA, United States

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/21/2002
Latest Refusal
10/21/2002
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1262×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
10/21/2002
74DRXELECTRODE, ELECTROCARDIOGRAPH
126FAILS STD
Chicago District Office (CHI-DO)
10/21/2002
74DRXELECTRODE, ELECTROCARDIOGRAPH
126FAILS STD
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Cardinal Health Inc.'s FDA import refusal history?

Cardinal Health Inc. (FEI: 1000148701) has 2 FDA import refusal record(s) in our database, spanning from 10/21/2002 to 10/21/2002.

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. Cardinal Health Inc.'s FEI number is 1000148701.

What types of violations has Cardinal Health Inc. received?

Cardinal Health 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 Cardinal Health Inc. come from?

All FDA import refusal data for Cardinal Health 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.