Shiseido Fine Toiletry Co Ltd
⚠️ Moderate Risk
FEI: 3002521358 • Shinagawa, Tokyo • JAPAN
FEI Number
3002521358
Location
Shinagawa, Tokyo
Country
JAPANAddress
2 Chome 3-12, Higashishinagawa, Shinagawa, 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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 5/4/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 5/4/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 5/4/2010 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 198COLOR LBLG | Los Angeles District Office (LOS-DO) |
| 2/22/2010 | 65CBL99NUTRIENT/TONIC N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 12/14/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 12/14/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 12/10/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 2/12/2002 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shiseido Fine Toiletry Co Ltd's FDA import refusal history?
Shiseido Fine Toiletry Co Ltd (FEI: 3002521358) has 10 FDA import refusal record(s) in our database, spanning from 2/12/2002 to 5/6/2010.
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 Fine Toiletry Co Ltd's FEI number is 3002521358.
What types of violations has Shiseido Fine Toiletry Co Ltd received?
Shiseido Fine Toiletry Co Ltd has been cited for 8 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 Fine Toiletry Co Ltd come from?
All FDA import refusal data for Shiseido Fine Toiletry 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.