Lion Company Ltd
⚠️ Moderate Risk
FEI: 3002343253 • Sumida, Tokyo • JAPAN
FEI Number
3002343253
Location
Sumida, Tokyo
Country
JAPANAddress
3 Raion ( Kabu 1, Honjo, Sumida, Tokyo, 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
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.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/21/2022 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 12/21/2022 | 63RIY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 12/21/2022 | 63RIY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/30/2022 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 9/30/2021 | 61HDJ99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2020 | 61HAY99ANTI-BACTERIAL, N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/14/2020 | 61HAY99ANTI-BACTERIAL, N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/14/2020 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 7/3/2018 | 89OTXFOOT WRAP FOR TREATING RESTLESS LEG SYNDROME SYMPTOMS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Lion Company Ltd's FDA import refusal history?
Lion Company Ltd (FEI: 3002343253) has 10 FDA import refusal record(s) in our database, spanning from 7/3/2018 to 12/21/2022.
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. Lion Company Ltd's FEI number is 3002343253.
What types of violations has Lion Company Ltd received?
Lion Company Ltd has been cited for 6 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 Lion Company Ltd come from?
All FDA import refusal data for Lion Company 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.