FUJIFIM CORPORATION

⚠️ Moderate Risk

FEI: 3015938913 • Ashigarakamigun • JAPAN

FEI

FEI Number

3015938913

📍

Location

Ashigarakamigun

🇯🇵

Country

JAPAN

🏢

Address

798, Miyanodia; Kiasei-Machi, Ashigarakamigun, , Japan

Moderate Risk

FDA Import Risk Assessment

47.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/20/2019

Latest Refusal

11/20/2019

Earliest Refusal

Score Breakdown

Violation Severity

56.7×40%

Refusal Volume

48.2×30%

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

11819×

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).

328019×

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.

50819×

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
11/20/2019	77EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	77EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FAJCYSTOSCOPE, DIAGNOSTIC	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	77EQNLARYNGOSCOPE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDSGASTROSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDSGASTROSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDSGASTROSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDSGASTROSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDSGASTROSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/20/2019	78FDFCOLONOSCOPE, GASTRO-UROLOGY	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FUJIFIM CORPORATION's FDA import refusal history?

FUJIFIM CORPORATION (FEI: 3015938913) has 19 FDA import refusal record(s) in our database, spanning from 11/20/2019 to 11/20/2019.

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. FUJIFIM CORPORATION's FEI number is 3015938913.

What types of violations has FUJIFIM CORPORATION received?

FUJIFIM CORPORATION has been cited for 3 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 FUJIFIM CORPORATION come from?

All FDA import refusal data for FUJIFIM 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.