Shiseido Co Ltd
⚠️ Moderate Risk
FEI: 3004414290 • Minato, Tokyo • JAPAN
FEI Number
3004414290
Location
Minato, Tokyo
Country
JAPANAddress
Higashi 162, Shinbashi, Minato, 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).
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.
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.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/10/2023 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/11/2023 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/10/2009 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 9/10/2009 | 53LY09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shiseido Co Ltd's FDA import refusal history?
Shiseido Co Ltd (FEI: 3004414290) has 5 FDA import refusal record(s) in our database, spanning from 9/10/2009 to 5/10/2023.
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. Shiseido Co Ltd's FEI number is 3004414290.
What types of violations has Shiseido Co Ltd received?
Shiseido Co Ltd has been cited for 5 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 Shiseido Co Ltd come from?
All FDA import refusal data for Shiseido 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.