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Cardinal Health

✅ Low Risk

FEI: 1017768 • Deland, FL • UNITED STATES

FEI

FEI Number

1017768

📍

Location

Deland, FL

🇺🇸
🏢

Address

2010 E International Speedway Blvd, , Deland, FL, United States

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/21/2019
Latest Refusal
2/21/2019
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
2/21/2019
76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
341REGISTERED
Division of Northeast Imports (DNEI)
2/21/2019
76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
341REGISTERED
Division of Northeast Imports (DNEI)
2/21/2019
76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Cardinal Health's FDA import refusal history?

Cardinal Health (FEI: 1017768) has 3 FDA import refusal record(s) in our database, spanning from 2/21/2019 to 2/21/2019.

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's FEI number is 1017768.

What types of violations has Cardinal Health received?

Cardinal Health 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 come from?

All FDA import refusal data for Cardinal Health 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.