Senjakuame-Honpo Co., Ltd. Himeji Factory
⚠️ Moderate Risk
FEI: 3010435126 • Himeji, Hyogo • JAPAN
FEI Number
3010435126
Location
Himeji, Hyogo
Country
JAPANAddress
841-33, Shirahama-Cho, Himeji, Hyogo, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/1/2021 | 66FBY99SUPPRESSANT N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/1/2021 | 66FBY99SUPPRESSANT N.E.C. | Division of West Coast Imports (DWCI) | |
| 8/1/2019 | 33YGT99CANDY WITHOUT CHOCOLATE N.E.C. | 11UNSAFE COL | Division of Northern Border Imports (DNBI) |
| 6/4/2019 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of West Coast Imports (DWCI) |
| 3/5/2019 | 33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of West Coast Imports (DWCI) |
| 3/14/2016 | 33EGT12MIXED/ASSORTED HARD CANDY WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Senjakuame-Honpo Co., Ltd. Himeji Factory's FDA import refusal history?
Senjakuame-Honpo Co., Ltd. Himeji Factory (FEI: 3010435126) has 6 FDA import refusal record(s) in our database, spanning from 3/14/2016 to 10/1/2021.
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. Senjakuame-Honpo Co., Ltd. Himeji Factory's FEI number is 3010435126.
What types of violations has Senjakuame-Honpo Co., Ltd. Himeji Factory received?
Senjakuame-Honpo Co., Ltd. Himeji Factory 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 Senjakuame-Honpo Co., Ltd. Himeji Factory come from?
All FDA import refusal data for Senjakuame-Honpo Co., Ltd. Himeji Factory 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.