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Fresenius Kabi USA LLC (FK USA)

✅ Low Risk

FEI: 3007344667 • Bensenville, IL • UNITED STATES

FEI

FEI Number

3007344667

📍

Location

Bensenville, IL

🇺🇸
🏢

Address

600 Supreme Dr, , Bensenville, 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
6/20/2003
Latest Refusal
6/20/2003
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
6/20/2003
56YCY99ANTIBIOTIC N.E.C.
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Fresenius Kabi USA LLC (FK USA)'s FDA import refusal history?

Fresenius Kabi USA LLC (FK USA) (FEI: 3007344667) has 1 FDA import refusal record(s) in our database, spanning from 6/20/2003 to 6/20/2003.

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. Fresenius Kabi USA LLC (FK USA)'s FEI number is 3007344667.

What types of violations has Fresenius Kabi USA LLC (FK USA) received?

Fresenius Kabi USA LLC (FK USA) 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 Fresenius Kabi USA LLC (FK USA) come from?

All FDA import refusal data for Fresenius Kabi USA LLC (FK USA) 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.