Sakura Shoten Inc.
⚠️ High Risk
FEI: 3004695527 • Fukuoka, JP-NOTA • JAPAN
FEI Number
3004695527
Location
Fukuoka, JP-NOTA
Country
JAPANAddress
3-14-2-234 Nagahama Chud - K 9, , Fukuoka, JP-NOTA, 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
IMPTRHACCP
The food appears to have been prepared, packed or held under insanitary conditions, or may have become injurious to health, due to the failure of the importer to provide verification of compliance pursuant to 21 CFR 123.12(d).
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.
USUAL NAME
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(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
BIO TOXIN
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/14/2007 | 16AGD22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | Los Angeles District Office (LOS-DO) | |
| 2/14/2007 | 16AGD99FISH, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/14/2007 | 16AGD22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 2/14/2007 | 16AGD22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 2/14/2007 | 16AGT22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 2/14/2007 | 16AGT79YELLOWTAIL, AMBERJACK | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 2/14/2007 | 16AGD99FISH, N.E.C. | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 2/14/2007 | 16AGT79YELLOWTAIL, AMBERJACK | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 2/14/2007 | 16JGD01CRAB | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 1/9/2007 | 16AGD22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 1/9/2007 | 16AGD22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 1/9/2007 | 16AGD22MACKEREL (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 1/9/2007 | 16AGT79YELLOWTAIL, AMBERJACK | 2000IMPTRHACCP | Los Angeles District Office (LOS-DO) |
| 8/21/2006 | 16AGD99FISH, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/14/2006 | 16AGD56FILEFISH | 260FALSE | Los Angeles District Office (LOS-DO) |
| 6/6/2006 | 16AFC65PUFFER | 2981BIO TOXIN | Los Angeles District Office (LOS-DO) |
| 6/6/2006 | 16XFC21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS | 473LABELING | Los Angeles District Office (LOS-DO) |
| 6/6/2006 | 16EYC99SHELLFISH, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/6/2006 | 16EYC99SHELLFISH, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/24/2006 | 16EYC02CLAMS | Los Angeles District Office (LOS-DO) | |
| 3/28/2006 | 16EGD02CLAMS | 308MFR INSAN | Los Angeles District Office (LOS-DO) |
| 3/28/2006 | 16EGD02CLAMS | 308MFR INSAN | Los Angeles District Office (LOS-DO) |
| 3/28/2006 | 16EGD02CLAMS | 308MFR INSAN | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sakura Shoten Inc.'s FDA import refusal history?
Sakura Shoten Inc. (FEI: 3004695527) has 23 FDA import refusal record(s) in our database, spanning from 3/28/2006 to 2/14/2007.
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. Sakura Shoten Inc.'s FEI number is 3004695527.
What types of violations has Sakura Shoten Inc. received?
Sakura Shoten Inc. has been cited for 7 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 Sakura Shoten Inc. come from?
All FDA import refusal data for Sakura Shoten Inc. 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.