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Japan Spectacles And Popular Optics Inspection Institution

✅ Low Risk

FEI: 3003637568 • Sabae, Fukui • JAPAN

FEI

FEI Number

3003637568

📍

Location

Sabae, Fukui

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 34, Shin'Yokoe, Sabae, Fukui, Japan

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
4/22/2016
Latest Refusal
4/22/2016
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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).

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

3411×

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
4/22/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
231LENS CERT
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Japan Spectacles And Popular Optics Inspection Institution's FDA import refusal history?

Japan Spectacles And Popular Optics Inspection Institution (FEI: 3003637568) has 1 FDA import refusal record(s) in our database, spanning from 4/22/2016 to 4/22/2016.

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. Japan Spectacles And Popular Optics Inspection Institution's FEI number is 3003637568.

What types of violations has Japan Spectacles And Popular Optics Inspection Institution received?

Japan Spectacles And Popular Optics Inspection Institution has been cited for 3 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 Japan Spectacles And Popular Optics Inspection Institution come from?

All FDA import refusal data for Japan Spectacles And Popular Optics Inspection Institution 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.