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OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant

⚠️ Moderate Risk

FEI: 3003637092 • Nishitama-Gun, Tokyo • JAPAN

FEI

FEI Number

3003637092

📍

Location

Nishitama-Gun, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

34-3, Oazahirai; Hinode-Machi, Nishitama-Gun, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/11/2010
Latest Refusal
8/11/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
8/11/2010
78KOGENDOSCOPE AND/OR ACCESSORIES
2780DEVICEGMPS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant's FDA import refusal history?

OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant (FEI: 3003637092) has 1 FDA import refusal record(s) in our database, spanning from 8/11/2010 to 8/11/2010.

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. OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant's FEI number is 3003637092.

What types of violations has OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant received?

OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant 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 OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant come from?

All FDA import refusal data for OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant 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.