Nadri Cosmetics Co., Ltd.
⚠️ Moderate Risk
FEI: 1000255302 • Seoul • SOUTH KOREA
FEI Number
1000255302
Location
Seoul
Country
SOUTH KOREAAddress
C.P.O. Box 9156, , Seoul, , South Korea
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).
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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 |
|---|---|---|---|
| 10/15/2002 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/18/2002 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/29/2002 | 53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/20/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Nadri Cosmetics Co., Ltd.'s FDA import refusal history?
Nadri Cosmetics Co., Ltd. (FEI: 1000255302) has 4 FDA import refusal record(s) in our database, spanning from 8/20/2002 to 10/15/2002.
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. Nadri Cosmetics Co., Ltd.'s FEI number is 1000255302.
What types of violations has Nadri Cosmetics Co., Ltd. received?
Nadri Cosmetics Co., Ltd. has been cited for 3 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 Nadri Cosmetics Co., Ltd. come from?
All FDA import refusal data for Nadri 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.