Ida Laboratories Co., Ltd.
⚠️ High Risk
FEI: 3004872954 • Tokyo • JAPAN
FEI Number
3004872954
Location
Tokyo
Country
JAPANAddress
Sumitomo-Ichigaya Bldg Ichigaya, , 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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
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.
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.
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).
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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 |
|---|---|---|---|
| 10/9/2025 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/18/2024 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 1/18/2024 | 53CY02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 4/12/2023 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/12/2023 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Ida Laboratories Co., Ltd.'s FDA import refusal history?
Ida Laboratories Co., Ltd. (FEI: 3004872954) has 5 FDA import refusal record(s) in our database, spanning from 4/12/2023 to 10/9/2025.
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. Ida Laboratories Co., Ltd.'s FEI number is 3004872954.
What types of violations has Ida Laboratories Co., Ltd. received?
Ida Laboratories 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 Ida Laboratories Co., Ltd. come from?
All FDA import refusal data for Ida Laboratories 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.