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HOYA Corporation PENTAX Miyagi Factory

⚠️ Moderate Risk

FEI: 3003782610 • Kurihara, Miyagi • JAPAN

FEI

FEI Number

3003782610

📍

Location

Kurihara, Miyagi

🇯🇵

Country

JAPAN
🏢

Address

30-2, Tsukidate, Kurihara, Miyagi, Japan

Moderate Risk

FDA Import Risk Assessment

34.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/22/2023
Latest Refusal
8/22/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
51.7×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
8/22/2023
78PEAENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
3280FRNMFGREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is HOYA Corporation PENTAX Miyagi Factory's FDA import refusal history?

HOYA Corporation PENTAX Miyagi Factory (FEI: 3003782610) has 1 FDA import refusal record(s) in our database, spanning from 8/22/2023 to 8/22/2023.

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. HOYA Corporation PENTAX Miyagi Factory's FEI number is 3003782610.

What types of violations has HOYA Corporation PENTAX Miyagi Factory received?

HOYA Corporation PENTAX Miyagi Factory 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 HOYA Corporation PENTAX Miyagi Factory come from?

All FDA import refusal data for HOYA Corporation PENTAX Miyagi Factory 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.