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TOPCON YAMAGATA

⚠️ Moderate Risk

FEI: 3012919371 • YAMAGATA • JAPAN

FEI

FEI Number

3012919371

📍

Location

YAMAGATA

🇯🇵

Country

JAPAN
🏢

Address

547 AZA ISIDA OAZA URUS, , YAMAGATA, , Japan

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
11/30/2018
Latest Refusal
11/30/2018
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

3414×

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
11/30/2018
86HKICAMERA, OPHTHALMIC, AC-POWERED
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)
11/30/2018
86HKICAMERA, OPHTHALMIC, AC-POWERED
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)
11/30/2018
86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)
11/30/2018
86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TOPCON YAMAGATA's FDA import refusal history?

TOPCON YAMAGATA (FEI: 3012919371) has 4 FDA import refusal record(s) in our database, spanning from 11/30/2018 to 11/30/2018.

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. TOPCON YAMAGATA's FEI number is 3012919371.

What types of violations has TOPCON YAMAGATA received?

TOPCON YAMAGATA 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 TOPCON YAMAGATA come from?

All FDA import refusal data for TOPCON YAMAGATA 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.