Inoue Shokuhin Co., Ltd. (Reizoko)
⚠️ High Risk
FEI: 3010182303 • Kobe, Hyogo • JAPAN
FEI Number
3010182303
Location
Kobe, Hyogo
Country
JAPANAddress
1-13, Tsukiji-Cho; Hyogo, Kobe, Hyogo, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
PB-FOOD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.
INCONSPICU
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2024 | 25PGT11ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI) | 256INCONSPICU | Division of West Coast Imports (DWCI) |
| 11/21/2023 | 25JGT24GINGER ROOT (ROOT & TUBER VEGETABLE) | 11UNSAFE COL | Division of West Coast Imports (DWCI) |
| 3/24/2022 | 21GGT14PLUM (PIT FRUIT) | 3400PB-FOOD | Division of West Coast Imports (DWCI) |
| 4/28/2020 | 33MHT05GEL CUPS CANDY | Division of West Coast Imports (DWCI) | |
| 4/28/2020 | 33MHT05GEL CUPS CANDY | Division of West Coast Imports (DWCI) | |
| 4/28/2020 | 33MHT05GEL CUPS CANDY | Division of West Coast Imports (DWCI) | |
| 5/14/2019 | 33MGT05GEL CUPS CANDY | Division of West Coast Imports (DWCI) | |
| 5/3/2019 | 16YGT17SAUCE, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/3/2019 | 25JGI24GINGER ROOT (ROOT & TUBER VEGETABLE) | Division of West Coast Imports (DWCI) | |
| 5/3/2019 | 25JCI21GARLIC BULB (ROOT & TUBER VEGETABLE) | Division of West Coast Imports (DWCI) | |
| 11/14/2018 | 16AGH01ANCHOVY | 308MFR INSAN | Division of West Coast Imports (DWCI) |
| 11/14/2018 | 16AGH01ANCHOVY | 308MFR INSAN | Division of West Coast Imports (DWCI) |
| 11/14/2018 | 16AGH01ANCHOVY | 308MFR INSAN | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 16YGT17SAUCE, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C. | 473LABELING | Division of West Coast Imports (DWCI) |
| 1/17/2018 | 16YGT17SAUCE, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C. | 473LABELING | Division of West Coast Imports (DWCI) |
| 12/20/2017 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 9/12/2017 | 24AGT19ADZUKI BEANS | Division of West Coast Imports (DWCI) | |
| 9/12/2017 | 25ECT99MIXED VEGETABLES, N.E.C. | 62NEEDS FCE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Inoue Shokuhin Co., Ltd. (Reizoko)'s FDA import refusal history?
Inoue Shokuhin Co., Ltd. (Reizoko) (FEI: 3010182303) has 18 FDA import refusal record(s) in our database, spanning from 9/12/2017 to 8/2/2024.
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. Inoue Shokuhin Co., Ltd. (Reizoko)'s FEI number is 3010182303.
What types of violations has Inoue Shokuhin Co., Ltd. (Reizoko) received?
Inoue Shokuhin Co., Ltd. (Reizoko) has been cited for 8 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 Inoue Shokuhin Co., Ltd. (Reizoko) come from?
All FDA import refusal data for Inoue Shokuhin Co., Ltd. (Reizoko) 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.