Fujifilm Corporation
⚠️ Moderate Risk
FEI: 3005930550 • Minato, Tokyo • JAPAN
FEI Number
3005930550
Location
Minato, Tokyo
Country
JAPANAddress
6-15, Minamiaoyama 6-Chome, MEDICAL SYSTEMS RESEARCH & DEVELOPMENT CENTER, Minato, Tokyo, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
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).
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 |
|---|---|---|---|
| 11/30/2023 | 78FADSTENT, URETERAL | Division of West Coast Imports (DWCI) | |
| 11/30/2023 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | Division of West Coast Imports (DWCI) | |
| 5/22/2023 | 78FDSGASTROSCOPE, GASTRO-UROLOGY | Division of Southeast Imports (DSEI) | |
| 4/20/2022 | 78FDSGASTROSCOPE, GASTRO-UROLOGY | Division of Southeast Imports (DSEI) | |
| 8/6/2020 | 78FDSGASTROSCOPE, GASTRO-UROLOGY | Division of Southeast Imports (DSEI) | |
| 8/6/2020 | 78GCQENDOSCOPE, FLEXIBLE | Division of Southeast Imports (DSEI) | |
| 2/28/2018 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/28/2018 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/28/2018 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/28/2018 | 79KQMCAMERA, SURGICAL AND ACCESSORIES | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/28/2018 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/28/2018 | 78FETTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/23/2015 | 78FDTDUODEDOSCOPE, ESOPHAGO GASTRO | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Fujifilm Corporation's FDA import refusal history?
Fujifilm Corporation (FEI: 3005930550) has 13 FDA import refusal record(s) in our database, spanning from 11/23/2015 to 11/30/2023.
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. Fujifilm Corporation's FEI number is 3005930550.
What types of violations has Fujifilm Corporation received?
Fujifilm Corporation 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 Fujifilm Corporation come from?
All FDA import refusal data for Fujifilm 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.