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Steris Japan Inc.

⚠️ Moderate Risk

FEI: 3003526615 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3003526615

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

801 Bay Wing Bldg, Kyo-Machi; Chuo, Kobe, Hyogo, 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
2/15/2002
Latest Refusal
2/15/2002
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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
2/15/2002
80FLESTERILIZER, STEAM
118NOT LISTED
508NO 510(K)
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Steris Japan Inc.'s FDA import refusal history?

Steris Japan Inc. (FEI: 3003526615) has 1 FDA import refusal record(s) in our database, spanning from 2/15/2002 to 2/15/2002.

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. Steris Japan Inc.'s FEI number is 3003526615.

What types of violations has Steris Japan Inc. received?

Steris Japan Inc. 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 Steris Japan Inc. come from?

All FDA import refusal data for Steris Japan Inc. 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.