Sangi Co.,Ltd.
⚠️ High Risk
FEI: 3000955642 • Chuo, Tokyo • JAPAN
FEI Number
3000955642
Location
Chuo, Tokyo
Country
JAPANAddress
3 Chome 11-6, Tsukiji, Chuo, Tokyo, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/7/2025 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2023 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 5/9/2022 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2019 | 63RIY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/26/2019 | 63RIY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/7/2019 | 63RIY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 2/7/2019 | 63RIY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/21/2018 | 62FBY07CETYLPYRIDINIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) | Division of Southeast Imports (DSEI) | |
| 12/19/2018 | 53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 12/19/2018 | 53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 473LABELING | Division of Southeast Imports (DSEI) |
| 12/19/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/7/2018 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/6/2018 | 63RBJ99DENTAL CARIES PROPHYLACTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/30/2018 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 11/14/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/28/2018 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Northern Border Imports (DNBI) | |
| 12/29/2017 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 11/16/2017 | 53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 3/24/2017 | 63RBY99DENTAL CARIES PROPHYLACTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/16/2017 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 9/30/2015 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Detroit District Office (DET-DO) |
| 9/26/2014 | 76EFWTOOTHBRUSH, MANUAL | Cincinnati District Office (CIN-DO) | |
| 4/16/2013 | 63RBL99DENTAL CARIES PROPHYLACTIC N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Sangi Co.,Ltd.'s FDA import refusal history?
Sangi Co.,Ltd. (FEI: 3000955642) has 25 FDA import refusal record(s) in our database, spanning from 4/16/2013 to 7/11/2025.
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. Sangi Co.,Ltd.'s FEI number is 3000955642.
What types of violations has Sangi Co.,Ltd. received?
Sangi Co.,Ltd. has been cited for 10 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 Sangi Co.,Ltd. come from?
All FDA import refusal data for Sangi 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.