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Fujisawa Ltd

⚠️ Moderate Risk

FEI: 3004495899 • Staines-upon-Thames, Middlesex • UNITED KINGDOM

FEI

FEI Number

3004495899

📍

Location

Staines-upon-Thames, Middlesex

🇬🇧
🏢

Address

62 London Road, , Staines-upon-Thames, Middlesex, United Kingdom

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/3/2004
Latest Refusal
5/3/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
5/3/2004
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Fujisawa Ltd's FDA import refusal history?

Fujisawa Ltd (FEI: 3004495899) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2004 to 5/3/2004.

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 Ltd's FEI number is 3004495899.

What types of violations has Fujisawa Ltd received?

Fujisawa Ltd 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 Ltd come from?

All FDA import refusal data for Fujisawa Ltd 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.