Fuji Photo Optical Co., Ltd.
⚠️ Moderate Risk
FEI: 3002807031 • Omiya, Saitama • JAPAN
FEI Number
3002807031
Location
Omiya, Saitama
Country
JAPANAddress
1 324, Utake, Omiya, Saitama, 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
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/27/2018 | 90IYBTUBE MOUNT, X-RAY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 2/28/2005 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 2/28/2005 | 78FBNCHOLEDOCHOSCOPE, FLEXIBLE OR RIGID | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 2/28/2005 | 78FDTDUODEDOSCOPE, ESOPHAGO GASTRO | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 2/28/2005 | 78FTJCOLONOSCOPE, GENERAL & PLASTIC SURGERY | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 2/28/2005 | 78FAMSIGMOIDOSCOPE, FLEXIBLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/28/2005 | 78GCKGASTROSCOPE, GENERAL & PLASTIC SURGERY | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 12/5/2002 | 78KYHENDOSCOPE, OPHTHALMIC | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Fuji Photo Optical Co., Ltd.'s FDA import refusal history?
Fuji Photo Optical Co., Ltd. (FEI: 3002807031) has 8 FDA import refusal record(s) in our database, spanning from 12/5/2002 to 7/27/2018.
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. Fuji Photo Optical Co., Ltd.'s FEI number is 3002807031.
What types of violations has Fuji Photo Optical Co., Ltd. received?
Fuji Photo Optical Co., Ltd. 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 Fuji Photo Optical Co., Ltd. come from?
All FDA import refusal data for Fuji Photo Optical Co., Ltd. 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.