RE&S Japan
⚠️ Moderate Risk
FEI: 3014793755 • Osaka, Osaka • JAPAN
FEI Number
3014793755
Location
Osaka, Osaka
Country
JAPANAddress
North 16-8 Osaka Central Wholesale Market, 1 Chome 1-86; Noda; Fukushima, Osaka, Osaka, 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
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2024 | 80FQMBANDAGE, ELASTIC | Division of West Coast Imports (DWCI) | |
| 3/10/2023 | 25JVC07RADISH (ROOT & TUBER VEGETABLE) | 64YELLOW #5 | Division of West Coast Imports (DWCI) |
| 11/29/2022 | 25JGC07RADISH (ROOT & TUBER VEGETABLE) | Division of West Coast Imports (DWCI) | |
| 11/29/2022 | 25JGC07RADISH (ROOT & TUBER VEGETABLE) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is RE&S Japan's FDA import refusal history?
RE&S Japan (FEI: 3014793755) has 4 FDA import refusal record(s) in our database, spanning from 11/29/2022 to 4/4/2024.
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. RE&S Japan's FEI number is 3014793755.
What types of violations has RE&S Japan received?
RE&S Japan has been cited for 5 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 RE&S Japan come from?
All FDA import refusal data for RE&S Japan 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.