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Fujisawa Health Care Inc

⚠️ Moderate Risk

FEI: 3002160581 • Deerfield, IL • UNITED STATES

FEI

FEI Number

3002160581

📍

Location

Deerfield, IL

🇺🇸
🏢

Address

3 Parkway N, , Deerfield, IL, United States

Moderate Risk

FDA Import Risk Assessment

29.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/11/2012
Latest Refusal
8/22/2008
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.9×10%
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

1792×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and 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
9/11/2012
63ECK18ADENOSINE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC))
179AGR RX
New Orleans District Office (NOL-DO)
8/22/2008
64TCJ08TACROLIMUS (IMMUNOSUPPRESSIVE)
179AGR RX
New York District Office (NYK-DO)

Frequently Asked Questions

What is Fujisawa Health Care Inc's FDA import refusal history?

Fujisawa Health Care Inc (FEI: 3002160581) has 2 FDA import refusal record(s) in our database, spanning from 8/22/2008 to 9/11/2012.

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. Fujisawa Health Care Inc's FEI number is 3002160581.

What types of violations has Fujisawa Health Care Inc received?

Fujisawa Health Care 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 Fujisawa Health Care Inc come from?

All FDA import refusal data for Fujisawa Health Care 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.