GE Healthcare Japan Corporation

⚠️ Moderate Risk

FEI: 3002808529 • Hino, Tokyo • JAPAN

FEI

FEI Number

3002808529

📍

Location

Hino, Tokyo

🇯🇵

Country

JAPAN

🏢

Address

Ge Herusukea.Japan ( Kabu -4 Chome 7-127, Asahigaoka, Hino, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

43.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/28/2023

Latest Refusal

1/27/2003

Earliest Refusal

Score Breakdown

Violation Severity

49.1×40%

Refusal Volume

46.5×30%

Recency

43.8×20%

Frequency

8.4×10%

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

34112×

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).

1186×

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).

4765×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

474×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

5084×

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.

32802×

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

Date	Product	Violations	Division
3/28/2023	90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC	341REGISTERED	Division of Southeast Imports (DSEI)
3/28/2023	90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC	341REGISTERED	Division of Southeast Imports (DSEI)
3/28/2023	90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC	341REGISTERED	Division of Southeast Imports (DSEI)
3/28/2023	90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC	341REGISTERED	Division of Southeast Imports (DSEI)
3/28/2023	90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC	341REGISTERED	Division of Southeast Imports (DSEI)
9/1/2017	90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Northern Border Imports (DNBI)
9/1/2017	90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Northern Border Imports (DNBI)
6/16/2015	90IZDPROBE, UPTAKE, NUCLEAR	118NOT LISTED 341REGISTERED 47NON STD	Division of Southeast Imports (DSEI)
12/10/2012	90IWYHOLDER, HEAD, RADIOGRAPHIC	118NOT LISTED 341REGISTERED 47NON STD 476NO REGISTR 508NO 510(K)	Chicago District Office (CHI-DO)
12/10/2012	90IWYHOLDER, HEAD, RADIOGRAPHIC	118NOT LISTED 341REGISTERED 47NON STD 476NO REGISTR 508NO 510(K)	Chicago District Office (CHI-DO)
3/23/2005	94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	476NO REGISTR	Cincinnati District Office (CIN-DO)
12/20/2004	90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC	508NO 510(K)	Florida District Office (FLA-DO)
11/3/2004	90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC	341REGISTERED	Florida District Office (FLA-DO)
10/20/2004	90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC	341REGISTERED	Florida District Office (FLA-DO)
8/6/2004	90IYEACCELERATOR, LINEAR, MEDICAL	476NO REGISTR	Chicago District Office (CHI-DO)
1/27/2003	74DPSELECTROCARDIOGRAPH	118NOT LISTED 508NO 510(K)	Minneapolis District Office (MIN-DO)
1/27/2003	95L30LASER PRINTERS	47NON STD 476NO REGISTR	Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is GE Healthcare Japan Corporation's FDA import refusal history?

GE Healthcare Japan Corporation (FEI: 3002808529) has 17 FDA import refusal record(s) in our database, spanning from 1/27/2003 to 3/28/2023.

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. GE Healthcare Japan Corporation's FEI number is 3002808529.

What types of violations has GE Healthcare Japan Corporation received?

GE Healthcare Japan Corporation has been cited for 6 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 GE Healthcare Japan Corporation come from?

All FDA import refusal data for GE Healthcare Japan Corporation 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.