Shin Nippon Commerce Inc

⚠️ Moderate Risk

FEI: 3004097705 • Tokyo • JAPAN

FEI

FEI Number

3004097705

📍

Location

Tokyo

🇯🇵

Country

JAPAN

🏢

Address

31 Ariake East Wing 7th Floor, , Tokyo, , Japan

Moderate Risk

FDA Import Risk Assessment

36.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/10/2005

Latest Refusal

6/14/2004

Earliest Refusal

Score Breakdown

Violation Severity

36.7×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

34110×

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).

5082×

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

Date	Product	Violations	Division
6/10/2005	86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER	341REGISTERED	Division of Southeast Imports (DSEI)
6/10/2005	86HNOKERATOME, AC-POWERED	341REGISTERED	Division of Southeast Imports (DSEI)
6/10/2005	86HOSPROJECTOR, OPHTHALMIC	341REGISTERED	Division of Southeast Imports (DSEI)
6/10/2005	86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER	341REGISTERED	Division of Southeast Imports (DSEI)
6/10/2005	86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED	341REGISTERED	Division of Southeast Imports (DSEI)
1/14/2005	86HLMINSTRUMENT, MEASURING, LENS, AC-POWERED	341REGISTERED	Florida District Office (FLA-DO)
1/14/2005	86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER	341REGISTERED	Florida District Office (FLA-DO)
12/6/2004	86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2004	86HNOKERATOME, AC-POWERED	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/14/2004	86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER	341REGISTERED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shin Nippon Commerce Inc's FDA import refusal history?

Shin Nippon Commerce Inc (FEI: 3004097705) has 10 FDA import refusal record(s) in our database, spanning from 6/14/2004 to 6/10/2005.

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. Shin Nippon Commerce Inc's FEI number is 3004097705.

What types of violations has Shin Nippon Commerce Inc received?

Shin Nippon Commerce 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 Shin Nippon Commerce Inc come from?

All FDA import refusal data for Shin Nippon Commerce 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.