Naris Cosmetics Co Ltd
⚠️ Moderate Risk
FEI: 1000258817 • Osaka, Osaka • JAPAN
FEI Number
1000258817
Location
Osaka, Osaka
Country
JAPANAddress
5 Chome 1-6, Ebie; Fukushima, Osaka, Osaka, 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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/26/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/4/2003 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/4/2003 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/4/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/4/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/4/2003 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/4/2003 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 3/6/2002 | 53RD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/6/2002 | 53RC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/6/2002 | 53RC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/6/2002 | 53RC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/6/2002 | 53RD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/6/2002 | 53RC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/6/2002 | 53RD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
| 3/6/2002 | 53RD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Naris Cosmetics Co Ltd's FDA import refusal history?
Naris Cosmetics Co Ltd (FEI: 1000258817) has 15 FDA import refusal record(s) in our database, spanning from 3/6/2002 to 8/26/2009.
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. Naris Cosmetics Co Ltd's FEI number is 1000258817.
What types of violations has Naris Cosmetics Co Ltd received?
Naris Cosmetics 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 Naris Cosmetics Co Ltd come from?
All FDA import refusal data for Naris Cosmetics 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.