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Fuji Chemicals Dev. Co. Ltd.

⚠️ Moderate Risk

FEI: 3000192481 • Chiyoda, Tokyo • JAPAN

FEI

FEI Number

3000192481

📍

Location

Chiyoda, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

3 Chome 20 1, Uchikanda, Chiyoda, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/8/2005
Latest Refusal
12/8/2005
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
12/8/2005
62VCS33NELFINAVIR MESYLATE (ANTI-VIRAL)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Fuji Chemicals Dev. Co. Ltd.'s FDA import refusal history?

Fuji Chemicals Dev. Co. Ltd. (FEI: 3000192481) has 1 FDA import refusal record(s) in our database, spanning from 12/8/2005 to 12/8/2005.

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. Fuji Chemicals Dev. Co. Ltd.'s FEI number is 3000192481.

What types of violations has Fuji Chemicals Dev. Co. Ltd. received?

Fuji Chemicals Dev. Co. Ltd. has been cited for 2 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 Fuji Chemicals Dev. Co. Ltd. come from?

All FDA import refusal data for Fuji Chemicals Dev. Co. 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.