Tohsiba Corp

⚠️ Moderate Risk

FEI: 3001130789 • Seto, Aichi • JAPAN

FEI

FEI Number

3001130789

📍

Location

Seto, Aichi

🇯🇵

Country

JAPAN

🏢

Address

1 Chome 1-1, Kitaura-Cho, Seto, Aichi, Japan

Moderate Risk

FDA Import Risk Assessment

31.6

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

8/7/2002

Earliest Refusal

Score Breakdown

Violation Severity

47.8×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

24.6×10%

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

3415×

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).

1262×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

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

Date	Product	Violations	Division
6/10/2005	90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/4/2004	90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
10/30/2003	90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC	341REGISTERED	Florida District Office (FLA-DO)
10/30/2003	90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC	341REGISTERED	Florida District Office (FLA-DO)
10/30/2002	90EGTCONTROLLER, TEMPERATURE, RADIOGRAPHIC	341REGISTERED	Florida District Office (FLA-DO)
8/7/2002	94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	126FAILS STD	New Orleans District Office (NOL-DO)
8/7/2002	94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	126FAILS STD	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Tohsiba Corp's FDA import refusal history?

Tohsiba Corp (FEI: 3001130789) has 7 FDA import refusal record(s) in our database, spanning from 8/7/2002 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. Tohsiba Corp's FEI number is 3001130789.

What types of violations has Tohsiba Corp received?

Tohsiba Corp has been cited for 4 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 Tohsiba Corp come from?

All FDA import refusal data for Tohsiba Corp 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.